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, low protein, that meets all of the requirements of ASTM standard D3578-91.

AI/ML Overview

The document describes the acceptance criteria and performance of "COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)".

1. Table of Acceptance Criteria and Reported Device Performance

TEST	Acceptance Criteria (ASTM D 3578-91)	Reported Device Performance (COMFIT Powder Free Blue Examination Gloves)
1. Watertight (1000 ml)	S-4, AQL 4.0	Pass based on AQL of 2.5
2. Length (mm)
Size S	min 230	297
Size M	min 230	303
Size L	min 230	300
Size XL	-	293
3. Palm width (mm)
Size S	80 ± 10	84
Size M	95 ± 10	95
Size L	111 ± 10	105
Size XL	-	118
4. Thickness (mm)
Finger	min 0.08	0.40
Palm	min 0.08	0.30
5. Physical Properties
Before Ageing :
Tensile Strength (MPa)	min 21	31.23
Ultimate Elongation (%)	min 700	895
After Ageing :
Tensile Strength (MPa)	min 16	26.64
Ultimate Elongation (%)	min 500	946
6. Powder Content	- (Implied maximum for "powder free")	below 2 mg / glove
7. Protein Content	- (Implied maximum for "low protein" and "hypoallergenic")	below 50 microgram / gram

2. Sample Size for the Test Set and Data Provenance

Non-Clinical Performance Data: The sample sizes for the physical and watertight tests (length, palm width, thickness, tensile strength, elongation, powder content) are not explicitly stated, but the performance is presented as single values for each metric for each size. The "Watertight (1000 ml)" test results are reported against an AQL (Acceptable Quality Limit) of 2.5, indicating a sampling plan was used according to the ASTM and FDA standards. The provenance of this data is not specified beyond being generated by the device manufacturer.
Clinical Performance Data (Hypoallergenic Claim):
- Sample Size: 200 human subjects.
- Data Provenance: Not explicitly stated, but implies a prospective clinical study conducted to assess the hypoallergenic claim.

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

Non-Clinical Performance Data: The document does not specify the number or qualifications of experts for establishing ground truth for the physical and chemical properties tests (e.g., tensile strength, protein content). These are standard laboratory tests typically performed by trained technicians according to established protocols (ASTM D 3578-91 and ASTM D5712 for protein content).
Clinical Performance Data (Hypoallergenic Claim): The "Modified Draize test" is mentioned, which is a standardized patch test for skin irritation and sensitization. This test involves clinical assessment by trained personnel, typically dermatologists or clinical researchers. However, the document does not specify the number or specific qualifications of the experts (e.g., dermatologists with X years of experience) involved in assessing the 200 human subjects.

4. Adjudication Method for the Test Set

Non-Clinical Performance Data: Not explicitly mentioned. Standardized tests (ASTM) usually have clear pass/fail criteria.
Clinical Performance Data (Hypoallergenic Claim): Not explicitly mentioned. The Modified Draize test results would likely involve trained evaluators assessing skin reactions, but an explicit adjudication method (e.g., independent review by multiple experts) is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This document pertains to the performance of examination gloves, not an AI-assisted diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a medical glove, not an algorithm or AI system. The performance evaluated is "standalone" in the sense that it's the raw physical and chemical properties of the glove.

7. The Type of Ground Truth Used

Non-Clinical Performance Data:
- Expert Consensus: Not explicitly stated. The "ground truth" for these measurements (e.g., length, tensile strength) is defined by the objective measurement obtained through validated laboratory testing methods (e.g., ASTM D 3578-91, ASTM D5712).
- Pathology/Outcomes Data: Not directly applicable. The data is based on physical and chemical measurements.
Clinical Performance Data (Hypoallergenic Claim):
- Clinical Assessment/Outcomes Data: The ground truth for the hypoallergenic claim was established through clinical observation and assessment of the human subjects for dermal irritation or sensitization using the Modified Draize test. The outcome (presence or absence of reaction) serves as the ground truth.

8. The Sample Size for the Training Set

This question is not applicable as the device is an examination glove, not a machine learning model that requires a training set. The manufacturing process and quality control would be "trained" through process optimization and adherence to standards, but not in the sense of a data-driven training set for an algorithm.

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

This question is not applicable for the reasons mentioned in point 8.

Summary

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K962188

CONTACT PERSON

(M) SDN BHD
Lot 1, Jalan 3
awasan Perusahaan Bandar Baru
Salak Tinggi, 43900 Sepang,
Selangor, Malaysia.
Corporate Office Tel: 8461486
8461867
Fax: 8461485
8461557
Factory Office: 8461495
8461496
Fax: 8461488
8461608

510 (K) SUMMARY

Trade Name : COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)

1. Common Name : Examination Gloves
1. Classification Name Patient Examination Glove

4. Substantial Equivalence :

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

6. Intended use of device :

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Image /page/0/Picture/14 description: The image shows a logo for a registered firm that meets the BS EN ISO 9002:1994 standards. The logo is circular with the letters "BSI" at the top. Inside the circle is a heart shape. The words "REGISTERED FIRM" are written around the circle.

Image /page/0/Picture/15 description: The image is a circular logo with the letter 'A' in the center. The words 'REGISTERED MANUFACTURER' are arranged around the top half of the circle, and 'OH' is located at the bottom. The logo appears to be a stamp or seal, possibly indicating registration or certification of a manufacturer.

GOOD MANUFACTURING PRACTICE
UK DEPARTMENT OF HEALTH
REGISTRATION NO. R0589/SP

Image /page/0/Picture/17 description: The image shows a logo with the word "REGISTERED" in a white oval shape. The oval is placed in the center of a diamond shape. The top and bottom triangles of the diamond are shaded in black. The word "MALAYSIA" is written below the diamond shape.

MALAYSIA
QUALITY SYSTEM MS ISO 9002 : 1991
REGISTRATION NO: AR 0027

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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 BlueExamination Gloves(Hypoallergenic, Low Protein)Pass based on AQL of 2.5
1. Watertight (1000 ml)	S-4, AQL 4.0
2. Length (mm)
Size
XS	-	-
S	min 230	297
M	min 230	303
L	min 230	300
XL	-	293
3. Palm width (mm)
Size
XS	-	-
S	80 ± 10	84
M	95 ± 10	95
L	111 ± 10	105
XL	-	118
4. Thickness (mm)
Finger	min 0.08	0.40
Palm	min 0.08	0.30
5. Physical Properties
Before Ageing :
Tensile Strength (MPa)	min 21	31.23
Ultimate Elongation (%)	min 700	895
After Ageing :
Tensile Strength (MPa)	min 16	26.64
Ultimate Elongation (%)	min 500	946
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.

Protein content tested on 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 : May 27, 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.