The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs.

Device Description

The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and nonsterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05 and Modified Draize 95 test.

AI/ML Overview

The provided document describes the safety and performance characteristics of a Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims (K181066), rather than an AI/ML powered medical device. Therefore, much of the requested information (e.g., AI/ML specific acceptance criteria, sample sizes for test/training sets, ground truth establishment methods, MRMC studies, standalone performance studies) is not applicable or available within this document.

However, I can extract and present the available information regarding the glove's acceptance criteria and the studies conducted to demonstrate its performance against those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	Acceptance Criteria	Reported Device Performance
Product Code	LZA, LZC	LZA, LZC
Intended Use	A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.	A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.
Material Use	Nitrile compound	Nitrile compound
Color	Blue	Blue
Sterility	Non sterile	Non sterile
Single Use	Single used	Single used
Dimensions	Overall Length (mm): Min 230mmWidth (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mmThickness at Palm (mm): Min; 0.05 mmThickness at Finger Tip (mm): Min 0.05 mm	Min 230mm (for length, width, and thickness values are specific to the given sizes and meet min 0.05mm for Palm and Finger Tip).
Physical Properties	Before Ageing:Tensile Strength (MPa) = 14minUltimate Elongation (%) = 500minAfter Aging at 70ºC for 168 hrs @ 100℃ for 22 hrs:Tensile Strength (MPa) = 14minUltimate Elongation (%) = 400min	Before aging:Tensile strength: Min 14 MpaUltimate Elongation: Min 500%After Aging:Tensile strength: Min 14 MpaUltimate Elongation: Min 400%
Freedom from pinholes	AQL 2.5, Inspection Level G-1	Meets ASTM D5151-06 (which specifies AQL 2.5, Inspection Level G-1)
Residual Powder	≤ 2.0 mg/pc	≤ 2.0 mg/pc
Biological Evaluation on Medical Device - Primary Skin Irritation Test	Not explicitly stated as a numerical value, but implied to be non-irritant.	Under the conditions of this study, the test article was a non-irritant.
Biological Evaluation on Medical Device - Dermal Sensitization Assay	Not explicitly stated as a numerical value, but implied to be non-sensitizer.	Under the conditions of this study, the test article was a non-sensitizer.
ISO 10993-5:2009 Biological Evaluation of Medical Device - Part 5: Test for In Vitro Cytotoxicity	Not explicitly stated as a numerical value, but implied to be non-cytotoxic.	Under the conditions of this study, the test article was not cytotoxic.
Resistance against Chemotherapy Drugs (Minimum Breakthrough Detection time in minutes)
1) Carmustine (BCNU)(3.3 mg/ml)		12.9 min
2) Cisplatin (1.0 mg/ml)		No breakthrough up to 240 min
3) Cyclophosphamide (Cytoxan)(20 mg/ml)		No breakthrough up to 240 min
4) Dacarbazine (DTIC) (10.0 mg/ml)		No breakthrough up to 240 min
5) Doxorubicin Hydrochloride (2.0 mg/ml)		No breakthrough up to 240 min
6) Etoposide (Toposar)(20.0 mg/ml)		No breakthrough up to 240 min
7) Fluorouracil (50.0 mg/ml)		No breakthrough up to 240 min
8) Paclitaxel (Taxol)(6.0 mg/ml)		No breakthrough up to 240 min
9) Thiotepa (10.0 mg/ml)		24.7 min
Low Dermatitis Potential Claim	No clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects	No Clinical evidence presence of residual chemical additives that may induce Type IV allergy in human subject

2. Sample Sizes Used for the Test Set and Data Provenance

Physical and Chemical Tests: The document refers to compliance with various ASTM standards (D6319-10, D5151-06, D6124-06, D6978-05). These standards prescribe specific sampling plans and test methods. The exact sample sizes used for each of these physical and chemical tests are not explicitly stated in this summary. The data provenance would be from laboratory testing according to these standards.
Biocompatibility/Low Dermatitis Potential Claim:
- Sample Size: A total of 205 human subjects were tested for the Modified Draize-95 test. This involved an initial population of 30, with a further number added to reach 205.
- Data Provenance: The study was a prospective human subject test conducted to evaluate the potential for irritation or sensitization. The document states the subjects "reasonably reflect the general user population in the US." The country of origin of the data is not explicitly stated, but the mention of "human subjects...in the US" could imply the study was conducted there, or at least designed to reflect a US population's response.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For the physical and chemical tests (e.g., tensile strength, pinholes, chemotherapy drug permeation), the "ground truth" is established by the direct measurement or observation of the glove's performance against the objective criteria set by the ASTM standards. No human consensus "experts" are typically involved in establishing this type of ground truth beyond the trained personnel performing the tests according to the standard operating procedures.
For the Low Dermatitis Potential Claim, the "ground truth" was established by the clinical observations of the 205 human subjects during the Modified Draize-95 test. The document states, "The study completed on 205 non sensitized adult human subjects... gave all negative results. There was no clinical evidence of the presence of residual chemical additives that may induce Type IV allergy..." This implies clinical evaluation by medical professionals, but the number and specific qualifications of these experts are not provided in the document.

4. Adjudication Method for the Test Set

For the physical and chemical tests, adjudication is based on whether the measured values meet the specified criteria in the ASTM standards.
For the Low Dermatitis Potential Claim via the Modified Draize-95 test, the outcome ("all negative results," "no clinical evidence") suggests a direct observation and interpretation by clinical evaluators rather than a formal multi-reader adjudication process like 2+1 or 3+1. The methodology would follow the specified FDA guidance document referenced.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not Applicable. This document describes a medical glove, not an AI/ML powered device. Therefore, no MRMC study involving human readers with or without AI assistance was conducted or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This document describes a medical glove, not an AI/ML powered device. Therefore, no standalone algorithm performance study was conducted or reported.

7. The Type of Ground Truth Used

Objective Measurement/Standard Compliance: For physical properties (dimensions, tensile strength, elongation, pinholes, residual powder) and chemotherapy drug resistance, the ground truth is based on direct laboratory measurements and adherence to established ASTM standards.
Clinical Observation: For the biocompatibility claims (primary skin irritation, dermal sensitization, cytotoxicity) and the low dermatitis potential claim, the ground truth is based on clinical observations and laboratory assays as per ISO 10993-10:2010, ISO10993-5, 16 CFR Part 1500.41, and the Modified Draize-95 test results on human subjects.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no AI/ML component, there is no training set or ground truth establishment for such a set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 26, 2018

ECO Medi Glove Sdn Bhd Suresh Kumar Quality Assurance Manager Lot 23826, Jalan Tembaga Kuning Kamunting Raya Industrial Estate Perak, 34600 My

Re: K181066

Trade/Device Name: Powder Free Examination Glove (Blue) with Low Dermatitis claim and with tested for use with Chemotherapy Drugs Claims Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: August 18, 2018 Received: August 27, 2018

Dear Suresh Kumar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Clarence W. Murray lii III -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181066

Device Name

Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with Chemotherapy Drugs Claims

Indications for Use (Describe)

Chemotherapy Drugs and Concentration

Minimum Breakthrough detection time in minutes(ug/cm2/minute)

1)Carmustine (BCNU)(3.3 mg/ml)(3,300ppm)	12.9
2)Cisplatin (1.0 mg/ml)(1,000ppm)	No breakthrough up to 240 min
3)Cyclophosphamide (Cytoxan)(20 mg/ml)(20,000ppm)	No breakthrough up to 240 min
4)Dacarbazine (DTIC) (10.0 mg/ml)(10,000ppm)	No breakthrough up to 240 min
5)Doxorubicin Hydrochloride (2.0 mg/ml)(2,000ppm)	No breakthrough up to 240 min
6)Etoposide (Toposar)(20.0 mg/ml)(20,000ppm)	No breakthrough up to 240 min
7)Fluorouracil (50.0 mg/ml)(50,000ppm)	No breakthrough up to 240 min
8)Paclitaxel (Taxol)(6.0 mg/ml)(6,000ppm)	No breakthrough up to 240 min
9)Thiotepa (10.0 mg/ml)(10,000ppm)	24.7

The Maximum testing time is 240 minutes. Please note that the following drugs have low permeation time: 1)Carmustine (BCNU)(3.3mg/ml)with Permeation time of 12.9 minutes. 2)Thiotepa ( 10.0mg/ml)with Permeation time of 24.7 minutes.

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary for K181066 Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with Tested for use with Chemotherapy Drugs Claims

1. Submitter:

Company Name:	ECO Medi Glove Sdn Bhd.
Company Address:	Lot 23826, Jalan Tembaga KuningKamunting Raya Industrial Estate,34600, TaipingPerak, Malaysia
Contact Person:	Mr Suresh Kumar
Telephone No:	603-60283033
Email:	qa1@riverstone.com.my

2. Preparation Date : 12th September 2018

3. Name of the Device

Trade Name / Proprietary Name:	Powder Free Nitrile Examination Glove (Blue)With Low Dermatitis Potential Claim and with testedfor Use with hemotherapy drugs Claims.
Device Name :	Nitrile Patient Examination gloves.
Device Classification Name :	Patient Examination gloves (21 CFR 880.6250).
Device Class :	Class I.
Product Code :	LZA , LZC.

4. Identification of The Legally Marketed Device:

Predicate Device: K152542, Powder Free Nitrile Examination (Blue) with Low Dermatitis Potential Claim with tested for use with Chemotherapy Drugs

5. Device Description

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Indication for Use:

The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for medical purpose that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

Test Chemotherapy Drug and Concentration	Minimum Breakthrough Detection time inminutes
1)Carmustine (BCNU) (3.3mg/ml)(3,300 ppm)	12.9
2) Cisplatin (1.0mg/ml)(1,000 ppm)	No breakthrough up to 240 min
3)Cyclophosphamide (Cytoxan)(20mg/ml)(20,000 ppm)	No breakthrough up to 240 min
4)Dacarbazine (DTIC)(10.0mg/ml)(10,000 ppm)	No breakthrough up to 240 min
5)Doxorubicin Hydrochloride ( 2.0mg/ml)(2,000 ppm)	No breakthrough up to 240 min
6)Etoposide (Toposar)(20.0mg/ml)(20,000 ppm)	No breakthrough up to 240 min
7)Fluorouracil (50.0mg/ml)(50,000 ppm)	No breakthrough up to 240 min
8)Paclitaxel (Taxol)(6.0mg/ml)(6,000 ppm)	No breakthrough up to 240 min
9)Thiotepa(10.0mg/ml)(10,000 ppm)	24.7

Maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time.

Carmustine (BCNU) (3.3mg/ml) with Permeation time of 12.9 minutes.
Thiotepa (10mg/ml) with Permeation time of 24.7 minutes

6. Specification for Nitrile gloves:

6.1.1 Dimension and Thickness of Gloves

Dimension	Size S	Size M	Size L	Size XL
Overall Length (mm)	230min	230min	230min	230min
Width (± 5mm)	85	95	105	115
Thickness at Palm (mm)	0.05min	0.05min	0.05min	0.05min
Thickness at Finger Tip (mm)	0.05min	0.05min	0.05min	0.05min

6.1.2 Gloves Physical Properties and Holes

Measurement	Before Ageing	After Aging at 70°C for168 hrs @ 100°C for 22 hrs
Tensile Strength (MPa)	14min	14 Min
Ultimate Elongation (%)	500min	400min
Pin-hole Level	AQL 2.5Inspection Level G-1	AQL 2.5Inspection Level G-1

Gloves meet all the specification listed in ASTM D 6319-10

6.1.3 Summary of the Technological Characteristics of the Device

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Characteristics	Acceptance Criteria	Powder Free NitrileExamination Gloves(Blue) withLow Dermatitis Potential Claimand with tested for use withchemotherapy drugs Claim,K181066	Powder Free NitrileExamination Glove (Blue) withLow Dermatitis Potential Claimand with tested for used withChemotherapy Drugs ,K152542	Comparison
Product Code	LZA, LZC	LZA, LZC	LZA, LZC	Same
Intended use	A powder free patientexamination glove is adisposable device intended formedical purposes that is wornon the examiner's hand orfinger to preventcontamination between patientand examiner. The device isfor over-the-counter use.	A powder free patientexamination glove is adisposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner. The deviceis for over-the-counter use.	A powder free patientexamination glove is adisposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner. The deviceis for over-the-counter use.	Same
Material use	Nitrilecompound	Nitrilecompound	Nitrilecompound	Same
Colour	Blue	Blue	Blue	Same
Sterility	Non sterile	Non sterile	Non sterile	Same
Single used	Single used	Single used	Single used	Same
Dimensions	Overall Length (mm)Min 230mmWidth (± 5mm)Size S = 85mmSize M = 95mmSize L = 105mmSize XL = 115mmThickness at Palm (mm)Min; 0.05 mmThickness at Finger Tip (mm)Min 0.05 mm	Min 230mm	Min 230mm	Same
Physical properties	Before AgeingTensile Strength (MPa)= 14minUltimate Elongation (%)= 500minAfter Aging at 70ºC for168 hrs @ 100℃ for 22 hrsTensile Strength (MPa)= 14minUltimate Elongation (%)= 400min	Before aging :Tensile strength: Min 14 MpaUltimate Elongation : Min 500%After Aging :Tensile strength: Min 14 MpaUltimate Elongation : Min 400%	Before aging :Tensile strength: Min 14 MpaUltimate Elongation : Min 500%After Aging :Tensile strength: Min 14 MpaUltimate Elongation : Min 400%	Same
Freedom frompinholes	AQL 2.5Inspection Level G-1	Meets ASTM D5151-06	Meets ASTM D5151-06	Same
Residual Powder	≤ 2.0 mg/pc	≤ 2.0 mg/pc	≤ 2.0 mg/pc	Same
BiologicalEvaluation onMedical Device --Primary SkinIrritation Test		Under the conditions of thisstudy, the test article was a non-irritant.	Under the conditions of thisstudy, the test article was a non-irritant.	Same
BiologicalEvaluation onMedical Device -DermalSensitizationAssay		Under the conditions of this study,the test article was a non-sensitizer.	Under the conditions of this study,the test article was a non-sensitizer.	Same
ISO 10993-5:2009	Biological Evaluation of MedicalDevice -Part 5: Test for In VitroCytotoxicity	Under the conditions of this study,the test article was not cytotoxic.	No test done	Similar
ResistanceagainstChemotherapyDrugs		1) Carmustine (3.3mg/ml or3000ppm), Breakthrough : 12.9 min.2) Cyclophosphamide (20mg/ml or20,000ppm), Breakthrough time:>240 min.3) Cisplatin (1mg/ml or 1000ppm),Breakthrough time > 240 min4)Doxorubicin Hydrochloride(2.0mg/ml or 2000ppm),Breakthrough time >240 min.5) Etoposide (20mg/ml or20,000ppm), Breakthrough time:>240 min.6) Flourouracil (50mg/ml or 50,000),Breakthrough time :>240 min.7) Dacarbazine (DTIC) (10mg/ml or10,000ppm), Breakthrough time: >240 min.8) Paclitaxel (6mg/ml or 6,000ppm),Breakthrough time >240 min.9) Thiotepa (10mg/ml or10,000ppm), Breakthrough time:24.7min.	1) Carmustine (3.3mg/ml or3000ppm), Breakthrough 20.1 min.2) Cyclophosphamide(20mg/ml or 20,000ppm),Breakthrough time: >240 min.3) Cisplatin (1mg/ml or 1000ppm),Breakthrough time: >240 min4)Doxorubicin Hydrochloride(2.0mg/ml or 2000ppm),Breakthrough time: >240 min.5) Etoposide (20mg/ml or20,000ppm), Breakthrough time:>240 min.6) Flourouracil (50mg/ml or 50,000),Breakthrough time : >240 min.7) Methotrexate (25mg/ml or25,000ppm), Breakthrough time: >240 min.8) Paclitaxel (6mg/ml or 6,000ppm),Breakthrough time:>240 min.9) Thiotepa (10mg/ml or10,000ppm), Breakthrough time:50.6 min.	Difference
Low DermatitisPotential Claim	1)Modified Draize 95 test	No Clinical evidence presence ofresidual chemical additives thatmay induce Type IV allergy inhuman subject	No Clinical evidence presence ofresidual chemical additives thatmay induce Type IV allergy inhuman subject	Same

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7. Summary of Non-Clinical Performance data

Testing was performed per ASTM D6319-10 , ASTM D5151-06, ASTM D6124-06,ISO 10993-10:2010 . ISO10993-5 and 16 CFR Part 1500.41. The glove meets standards requirement referenced in section 6.0 above. Biocompatibility test indicates the gloves are not a contact skin sensitizer, not a primary skin irritant, and not cytotoxic.

8. Summary of Clinical Performance Data

Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and tested for Use with Chemotherapy drugs were tested in accordance with Modified Draize -95 test , per FDA's guidance document "Guidance for Industry and FDA Reviewer/Staffs: Premarket Notification [510k] Submissions for testing for skin sensitization to chemical in natural Rubber Products".

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The study was conducted in two stages. In the first, a population of 30 human subjects was tested to evaluate the product for the potential to cause irritation or sensitization. The second stage was initiated on a further number of subjects to a total of a minimum 205 individuals after the first stage has shown that the test product does not indicate a potential for inducing dermal irritation and does not shown sensitization capability

The study completed on 205 non sensitized adult human subjects, who reasonably reflect the general user population in the US, gave all negative results. There was no clinical evidence of the presence of residual chemical additives at the level that may induce type IV allergy in the un-sensitized general user population in the tested articles.

9. Conclusion

The conclusions drawn from the nonclinical and clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.