FDA Regulation of FDA Regulation of Medical GlovesMedical Gloves

Glove Standards and the 510(k) ProcessGlove Standards and the 510(k) Process

Terrell CunninghamTerrell CunninghamScientific ReviewerScientific Reviewer

Infection Control Devices BranchInfection Control Devices BranchDivision of Anesthesiology, General Hospital, Division of Anesthesiology, General Hospital,

Infection Control and Dental DevicesInfection Control and Dental DevicesCenter for Devices and Radiological Health, Center for Devices and Radiological Health,

US Food and Drug AdministrationUS Food and Drug AdministrationIOM Meeting April 13, 2010IOM Meeting April 13, 2010

2

IOM ISSUESIOM ISSUES

nn What is the current FDA Review Process? What is the current FDA Review Process?

nn What standards are required to be met for FDA What standards are required to be met for FDA 510(k) clearance?510(k) clearance?

3

TopicsTopics

nn Regulatory Review ProcessRegulatory Review Processnn DefinitionsDefinitionsnn Device Classification Device Classification nn Performance RequirementsPerformance Requirementsnn Labeling RequirementsLabeling Requirements

nn Use of Recognized Consensus StandardsUse of Recognized Consensus Standards

4

FDA Definition of Medical DevicesFDA Definition of Medical Devices

Medical devices are “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or animals”

5

PREMARKETNOTIFICATION 510(K)

A marketing application submitted to FDA to demonstrate that the subject device is as safe and as effective (substantially equivalent)to an existing legally marketed (predicate) device

6

510(k) Premarket Notification 510(k) Premarket Notification SubmissionSubmission

nn Identification and Description of the DeviceIdentification and Description of the Devicenn Identification of and Comparison to a Legally Identification of and Comparison to a Legally

Marketed Predicate DeviceMarketed Predicate Devicenn Statement of Indications for UseStatement of Indications for Usenn Risk Analysis/Mitigation Demonstrated by Risk Analysis/Mitigation Demonstrated by

Performance TestingPerformance Testingnn Labeling ReviewLabeling Review

7

Classification of Medical GlovesClassification of Medical Gloves

nn SurgeonSurgeon’’s Glove s Glove –– Class I Class I (21 CFR 878.4460)(21 CFR 878.4460)

nn Examination Glove Examination Glove –– Class I Class I (21 CFR 880.6250)(21 CFR 880.6250)

nn Premarket Notification [Premarket Notification [510(k)] is required510(k)] is requiredprior to marketing prior to marketing ALL medical glovesALL medical gloves in in U.S.U.S.

8

Patient Examination Gloves Patient Examination Gloves 21 CFR 880.625021 CFR 880.6250

nn ““A patient examination glove is a disposable A patient examination glove is a disposable device intended for medical purposes that is device intended for medical purposes that is worn on the examiner's hand or finger to worn on the examiner's hand or finger to prevent contamination between patient and prevent contamination between patient and examiner.examiner.””

nn Primarily NonPrimarily Non--SterileSterilenn SingleSingle--Use/DisposableUse/Disposablenn Barrier Protection Barrier Protection

Protects wearerProtects wearer from bloodfrom blood--and fluidand fluid--borne borne pathogenspathogens

9

nn ““ A surgeon's glove is a device made of natural A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by or synthetic rubber intended to be worn by operating room personnel to protect a surgical operating room personnel to protect a surgical wound from contamination.wound from contamination.””

nn SterileSterile

nn SingleSingle--Use/DisposableUse/Disposable

nn Barrier Protection Barrier Protection Protects patientProtects patient from transmission of microorganisms and from transmission of microorganisms and crosscross--infectioninfection

SurgeonSurgeon’’s Glove s Glove 21 CFR 878.446021 CFR 878.4460

10

Three Regulatory Classesof Medical Devices

n Class I : Low risk - General Control -510(k) exempt (mostly)

n Class II : Intermediate risk - Special &General Control – 510(k)

n Class III : High risk – Premarket Approval (PMA)

11

FDA Regulation of Medical Devices FDA Regulation of Medical Devices General Controls General Controls

nn Premarket Notification Submission [510(k)]Premarket Notification Submission [510(k)]nn Establishment RegistrationEstablishment Registrationnn Medical Device ListingMedical Device Listingnn Good Manufacturing Practices Good Manufacturing Practices

Quality System Regulation (QSR)Quality System Regulation (QSR)nn Labeling RequirementsLabeling Requirementsnn Medical Device Reporting of Adverse Medical Device Reporting of Adverse

EventsEvents

12

FDA Regulation of Medical Devices FDA Regulation of Medical Devices Special ControlsSpecial Controls

nn FDA Guidance Documents FDA Guidance Documents nn Regulatory Performance StandardsRegulatory Performance Standardsnn Special Labeling RequirementsSpecial Labeling Requirementsnn Special User Education and TrainingSpecial User Education and Trainingnn Patient RegistriesPatient Registriesnn Postmarket SurveillancePostmarket Surveillance

nn **Medical gloves are not subject to special controlsMedical gloves are not subject to special controls..

13

Medical Glove Guidance DocumentMedical Glove Guidance Document

nn FDA recommends that medical gloves cleared FDA recommends that medical gloves cleared for marketing meet the minimum performance for marketing meet the minimum performance specifications described in the Guidance for specifications described in the Guidance for Industry and FDA Staff Industry and FDA Staff -- Medical Glove Medical Glove Guidance Manual issued January 22, 2008 Guidance Manual issued January 22, 2008

nn This document may be found at This document may be found at http://www.fda.gov/MedicalDevices/Devicehttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocumentsRegulationandGuidance/GuidanceDocuments/ucm073111.htm/ucm073111.htm

14

FDA Recognized Consensus FDA Recognized Consensus StandardsStandards

nn Recognized Consensus Standards and FDA Guidance Recognized Consensus Standards and FDA Guidance documents facilitate the premarket review process.documents facilitate the premarket review process.

nn Conformance with Recognized Consensus Standards Conformance with Recognized Consensus Standards can provide reasonable assurance of safety and can provide reasonable assurance of safety and effectiveness for many aspects of medical device effectiveness for many aspects of medical device evaluation.evaluation.

nn Standards produce voluntary consensus among Standards produce voluntary consensus among industry, health care device users and FDA.industry, health care device users and FDA.

nn Standards are updated as technology and experience Standards are updated as technology and experience advance.advance.

15

Medical Gloves Medical Gloves Material CompositionMaterial Composition

nn Natural Rubber Latex Natural Rubber Latex nn Guayule Guayule

nn Synthetic PolymersSynthetic Polymersnn Vinyl Vinyl nn PolychloroprenePolychloroprenenn Polyurethane Polyurethane nn Isoprene Isoprene nn NitrileNitrilenn Neoprene/styrene/styreneNeoprene/styrene/styrene--butadienebutadiene

nn Chemical Additives Chemical Additives

16

Use of Consensus Standards Use of Consensus Standards ––Testing of Medical GlovesTesting of Medical Gloves

nn Latex Gloves ASTM D 3578:2005Latex Gloves ASTM D 3578:2005nn Vinyl Gloves ASTM D 5250:2006Vinyl Gloves ASTM D 5250:2006nn Synthetic Polymer Gloves ASTM D6977:2004Synthetic Polymer Gloves ASTM D6977:2004

ASTM D3578:2005ASTM D3578:2005nn Nitrile Gloves ASTM D6319:2005Nitrile Gloves ASTM D6319:2005nn SurgeonsSurgeons’’ Gloves ASTM D 3577:2006Gloves ASTM D 3577:2006

17

510(k) Review Process for Medical Gloves510(k) Review Process for Medical GlovesPerformance RequirementsPerformance Requirements

nn Glove SpecificationsGlove Specificationsnn Water Leak Test (Pinhole AQL) Water Leak Test (Pinhole AQL) nn Physical Properties Physical Properties --Tensile Strength/ElongationTensile Strength/Elongationnn Physical DimensionsPhysical DimensionsnnLength, width, thicknessLength, width, thickness

nn Powder Free ResiduePowder Free Residuenn Protein Content (gloves made of natural rubber Protein Content (gloves made of natural rubber

latex) latex) nn Powder AmountPowder Amount

18

510(k) Review Process for Medical Gloves510(k) Review Process for Medical GlovesPerformance RequirementsPerformance Requirements

nn Biocompatibility Biocompatibility nn Skin IrritationSkin Irritationnn Dermal SensitizationDermal Sensitization

nn Sterilization Method and Validation (as Sterilization Method and Validation (as appropriate)appropriate)nn Gloves should be tested to ensure that they meet the Gloves should be tested to ensure that they meet the

respective listed glove specifications AFTER respective listed glove specifications AFTER sterilizationsterilization

19

Use of Consensus Standards Use of Consensus Standards --Testing of Medical GlovesTesting of Medical Gloves

nn Detection of HolesDetection of Holesnn ASTM D 5151ASTM D 5151--99(2006)99(2006)

nn Biocompatibility Biocompatibility nn ISOISO--1099310993--11: Biological Evaluation of Medical: Biological Evaluation of Medical

Devices Part 1: Evaluation and TestingDevices Part 1: Evaluation and Testing

nn Resistance to PermeationResistance to Permeation--Chemotherapy Chemotherapy DrugsDrugsnn ASTM D6978:2005ASTM D6978:2005

20

Use of Consensus Standards Use of Consensus Standards ––Testing of Medical GlovesTesting of Medical Gloves

STERILIZATIONSTERILIZATIONnn ANSI/AAMI/ISO 11135ANSI/AAMI/ISO 11135-- Medical devices Medical devices --

Validation and routine control of ethylene oxide Validation and routine control of ethylene oxide sterilizationsterilization

nn AAMI/CDV 11137 Sterilization of health care AAMI/CDV 11137 Sterilization of health care products products –– RadiationRadiation

nn AAMI/ISO Technical Information Report AAMI/ISO Technical Information Report (TIR) 13409 Sterilization of health care products (TIR) 13409 Sterilization of health care products -- Radiation sterilizationRadiation sterilization

21

510(k) Review Process for Medical Gloves 510(k) Review Process for Medical Gloves LabelingLabeling

nn Directions For UseDirections For Usenn Satisfy requirements of 21 CFR 807.87(e) and 21 CFR part Satisfy requirements of 21 CFR 807.87(e) and 21 CFR part

801801

nn Single Use/Disposable Single Use/Disposable

nn All medical gloves containing natural rubber All medical gloves containing natural rubber latex must be labeled in bold print as required by latex must be labeled in bold print as required by 21 CFR 800.43(d)21 CFR 800.43(d)nn ““Caution: This Product Contains Natural Rubber Caution: This Product Contains Natural Rubber

Latex Which May Cause Allergic ReactionsLatex Which May Cause Allergic Reactions””

22

Use of Consensus Standards Use of Consensus Standards LabelingLabeling

Attribute LabelingAttribute Labelingnn PowderPowder--Free 2mg or less of residual powderFree 2mg or less of residual powder

nn ASTM D 6124:2001ASTM D 6124:2001

nn Reduced Protein Level 50ugm/dmReduced Protein Level 50ugm/dm22 or less of or less of extractable proteinextractable proteinnn ASTM D 5712:2005e1 (Lowry Test)ASTM D 5712:2005e1 (Lowry Test)nn ASTM D 6499:2003 Measurement of Antigenic ProteinASTM D 6499:2003 Measurement of Antigenic Protein

nn Expiration Dating for Medical GlovesExpiration Dating for Medical Glovesnn ASTM D7160ASTM D7160--0505

23

FDA Postmarket ActivitiesFDA Postmarket ActivitiesSurveillance Surveillance

nn The Medical Device Reporting regulation is a The Medical Device Reporting regulation is a mechanism for FDA and manufacturers to mechanism for FDA and manufacturers to identify and monitor significant adverse events identify and monitor significant adverse events involving medical devices. involving medical devices. nn Medical Device Reporting (MDR)Medical Device Reporting (MDR)nn MedWatch 1MedWatch 1--800800--FDAFDA--1088 1088 nn Safety Alerts & Public Health AdvisoriesSafety Alerts & Public Health Advisoriesnn Medical BulletinsMedical Bulletins

24

FDA Post Market Activities FDA Post Market Activities ComplianceCompliance

nn Factory InspectionsFactory Inspectionsnn FDA Sampling and TestingFDA Sampling and Testingnn Detention Detention nn Regulatory SanctionsRegulatory Sanctionsnn AdulterationAdulterationnn Misbranding Misbranding

nn Recalls and Safety Alerts Recalls and Safety Alerts

25

FDA/CDRH Responsibilities for FDA/CDRH Responsibilities for Regulation of Medical GlovesRegulation of Medical Gloves

n Evaluate and clear medical gloves for marketing to ensure they are safe and effective

n Inspect manufacturing facilities to ensure the quality of devices

n Surveillance and Compliance n Take corrective actions to remove devices from

commercial distribution when they are unsafe, misbranded, or adulterated

n Promote development and use of standardsn Communicate and educate consumers

26

Where Can I Find Out More?Where Can I Find Out More?

nn General information:General information:http://www.fda.gov/MedicalDevices/ProductsandMedichttp://www.fda.gov/MedicalDevices/ProductsandMedic

alProcedures/GeneralHospitalDevicesandSupplies/PeralProcedures/GeneralHospitalDevicesandSupplies/PersonalProtectiveEquipment/ucm056084.htmsonalProtectiveEquipment/ucm056084.htm

http://www.fda.gov/MedicalDevices/Safety/default.htmhttp://www.fda.gov/MedicalDevices/Safety/default.htm

nn For copies of slides: For copies of slides: TTerrell.Cunningham@fda.hhs.gov errell.Cunningham@fda.hhs.gov (301) 796(301) 796--6299 6299

27

Thank YouThank You

Questions/Comments?Questions/Comments?