The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Device Description

Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, protein labeling content, that meets all of the requirements of ASTM standard D3578-91.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

TEST	Acceptance Criteria (ASTM D 3578-91 & FDA)	COMFIT Powder Free Latex Examination Gloves Performance
1. Watertight (1000 ml)	S-4, AQL 4.0	Pass based on AQL of 2.5
2. Length (mm)
Size S	min 230	242
Size M	min 230	238
Size L	min 230	239
3. Palm width (mm)
Size S	$80 \pm 10$	85
Size M	$95 \pm 10$	96
Size L	$111 \pm 10$	105
4. Thickness (mm)
Finger	min 0.08	0.25
Palm	min 0.08	0.19
5. Physical Properties
Before Ageing:
Tensile Strength (MPa)	min 21	28.4
Ultimate Elongation (%)	min 700	873
After Ageing:
Tensile Strength (MPa)	min 16	25.8
Ultimate Elongation (%)	min 500	854
6. Powder Content	-	below 2 mg / glove
7. Protein Content	-	below 50 microgram / gram

Sample size used for the test set and the data provenance:
- Watertight test: "S-4, AQL 4.0" and "AQL of 2.5" relate to sampling plans (e.g., ISO 2859-1 or MIL-STD-105E). While the exact sample size isn't explicitly stated, these AQL levels imply a statistically determined sample size for lot release testing based on batch quantity.
- Clinical data (Modified Draize test): 200 human subjects.
- Data Provence: Not explicitly stated, but the manufacturer is Wembley Rubber Products (M) Sdn Bhd in Selangor, Malaysia, suggesting the testing was likely conducted in Malaysia or a related region, or according to international standards. The data is retrospective for the purpose of this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the physical and chemical property tests (watertight, length, width, thickness, tensile strength, elongation, powder, and protein content), the "ground truth" is established by the specifications defined in ASTM D 3578-91 and FDA 1000 ml watertight test. These are standardized tests with objective measurements, not typically requiring individual expert consensus for ground truth but rather adherence to validated testing methodologies by qualified technicians.
- For the Modified Draize test, the "ground truth" regarding dermal irritation or sensitization is established by the clinical assessment of the 200 human subjects by qualified personnel (e.g., dermatologists or clinical researchers experienced in dermatological assessments). The number and specific qualifications of these experts are not detailed in the provided text.
Adjudication method for the test set:
- For the physical and chemical tests, adjudication is not typically used as the tests yield objective, quantitative results against defined criteria. A "pass" or "fail" is determined directly by measurement against the standard.
- For the Modified Draize test, the determination of "no potential for eliciting either dermal irritation or sensitization" would be based on the assessment of the clinical researchers overseeing the study. The specific adjudication method (e.g., blind assessment, multiple reader agreement) is not specified.
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:
- No, this document pertains to the performance testing of a physical medical device (examination gloves), not an AI-powered diagnostic or interpretive system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is for a physical medical device.
The type of ground truth used:
- For physical and chemical properties: Objective criteria defined by recognized standards (ASTM D 3578-91) and regulatory requirements (FDA 1000 ml watertight test).
- For hypoallergenic claim: Clinical outcomes data from a Modified Draize test on 200 human subjects (dermal irritation and sensitization results).
The sample size for the training set:
- Not applicable. This document describes performance testing of a manufactured product against standards, not the development or training of an algorithm.
How the ground truth for the training set was established:
- Not applicable.

Summary

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OCT 11 1996

Image /page/0/Picture/1 description: The image shows a logo with the letters "WRP" in bold, black font. The letters are arranged horizontally, with "W" on the left, "R" in the middle, and "P" on the right. The letters are enclosed in a black, rounded rectangular border. The logo appears to be a simple, stylized design.

K953213

CONTACT PERSON: MR.

Wembley Rubber Products (M) Sdn Bhd

Marketing / Factory Lot 1, Jalan 3 Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 SEPANG Selangor, Malaysia Telex: MA 39599 WRP Tel: +603-846 1486 Fax: +603-846 1557

APPENDIX 4 510 (K) SUMMARY

1. Trade Name : COMFIT POWDER FREE LATEX EXAMINATION GLOVES (HYPOALLERGENIC, BEADED, PROTEIN LABELING CONTENT)
: Examination Gloves 2. Common Name
1. Classification Name : Patient Examination Glove

4. Substantial Equivalence :

Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, protein labeling content, that meets all of the requirements of ASTM standard D3578-91.

5. Description of device :

Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, protein labeling content, that meets all of the requirements of ASTM standard D3578-91.

6. Intended use of device :

Image /page/0/Picture/18 description: The image shows a black and white symbol that appears to be a stylized representation of a heart or an inverted triangle within a circular or semi-circular frame. The heart or triangle shape is positioned in the center of the frame, with a horizontal line across the top of the shape. The frame itself is thick and dark, with some irregularities or breaks in the outer edge, giving it a slightly distressed or worn appearance.

Image /page/0/Picture/19 description: The image shows a circular logo with the letter 'A' in the center. The words 'REGISTERED MANUFACTURER' are arranged around the letter 'A' in a circular fashion. The logo appears to be a stamp or seal, and the text is in a bold, sans-serif font.

Image /page/0/Picture/20 description: The image shows a black and white logo with the word "REGISTERED" in a sans-serif font. The logo is in the shape of a rounded pentagon. There is a thick black line at the bottom of the pentagon.

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7. Summary of Performance data :

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Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test.

TEST	ASTM D 3578-91	COMFIT Powder Free LatexExamination Gloves (Hypo,Beaded, Protein LabelingContent)
1. Watertight (1000 ml)	S-4, AQL 4.0	Pass based on AQL of 2.5
2. Length (mm)
Size XS	-	240
Size S	min 230	242
Size M	min 230	238
Size L	min 230	239
Size XL	-	240
3. Palm width (mm)
Size XS	-	79
Size S	$80 \pm 10$	85
Size M	$95 \pm 10$	96
Size L	$111 \pm 10$	105
Size XL	-	110
4. Thickness (mm)
Finger	min 0.08	0.25
Palm	min 0.08	0.19
5. Physical Properties
Before Ageing:
Tensile Strength (MPa)	min 21	28.4
Ultimate Elongation (%)	min 700	873
After Ageing:
Tensile Strength (MPa)	min 16	25.8
Ultimate Elongation (%)	min 500	854
6.Powder Content	-	below 2 mg / glove
7.Protein Content	-	below 50 microgram / gram

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8 . Substantial Equivalence based on assessment of Non-Clinical performance data

The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578-91.

moves roquirements of recently manufactured and accelerated ageing gloves using ASTM D5712 is below 50 microgram / gram.

9. Assessment of Clinical Performance data

Clinical data of 200 Human subjects on Modified Draize test done on this glove demonstrated no potential for eliciting either dermal irritation or sensitization and support the labeling claim for "hypoallergenic".

10. Conclusion

This glove exceed the ASTM D 3578-91 requirements, meet pinhole FDA requirements, meet Hypoallergenic labeling claim and below 50 microgram / gram protein content labeling claim.

Date Summary Prepared : June 05, 1996

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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.