COMFIT

K953590 · Wembley Rubber Products (M) Sdn Bhd · LYY · Jun 27, 1996 · General Hospital

Device Facts

• Record ID: K953590
• Device Name: COMFIT
• Applicant: Wembley Rubber Products (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jun 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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 Story

Device is a powder-free, hypoallergenic, un-beaded latex examination glove. Worn by healthcare and operating room personnel to provide a protective barrier against contamination from patient fluids, waste, or environment. Device is a single-use, disposable physical barrier. No electronic or mechanical components.

Clinical Evidence

Clinical study conducted on 200 human subjects using the Modified Draize test. Results demonstrated no potential for dermal irritation or sensitization, supporting the 'hypoallergenic' labeling claim.

Technological Characteristics

Material: Latex. Powder-free (<2 mg/glove). Protein content <50 µg/g. Meets ASTM D3578-91 standards for dimensions, tensile strength (min 21 MPa before aging), and ultimate elongation (min 700% before aging). Watertight integrity tested per FDA 1000 ml test.

Indications for Use

Indicated for use by healthcare and operating room personnel as a protective barrier to prevent cross-contamination between the wearer and the patient's body, fluids, waste, or environment.

Regulatory Classification

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.

Submission Summary (Full Text)

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JUN 27 1996
K95 3590
WRP
Contact person: Y.W. CHOW
WEMBLEY RUBBER PRODUCTS
(M) SDN BHD
Lot 1, Jalan 3
Kawasan Perusahaan Bandar Baru
Salak Tinggi, 43900 Sepang,
Selangor, Malaysia.
Corporate Office Tel: [phone]
8461867
Fax: [phone]
8461557
Factory Office: 8461495
8461496
Fax: [phone]
8461608

# APPENDIX 4

## 510 (K) SUMMARY

1. **Trade Name** : COMFIT POWDER FREE LATEX EXAMINATION GLOVES (HYPOALLERGENIC, UNBEADED, PROTEIN LABELING CONTENT)

2. **Common Name** : Examination Gloves

3. **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** :

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.

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# 7. Summary of Performance data :

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

| TEST | ASTM D 3578-91 | COMFIT Powder Free Latex Examination Gloves (Hypo, Unbeaded, Protein Labeling Content) |
| --- | --- | --- |
| 1. Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 2.5 |
| 2. Length (mm) | | |
| Size
XS
S
M
L
XL | -
min 230
min 230
min 230
- | 275
287
282
284
275 |
| 3. Palm width (mm) | | |
| Size
XS
S
M
L
XL | -
80 ± 10
95 ± 10
111 ± 10
- | 79
83
93
103
110 |
| 4. Thickness (mm) | | |
| Finger
Palm | min 0.08
min 0.08 | 0.25
0.22 |
| 5. Physical Properties | | |
| Before Ageing : | | |
| Tensile Strength (MPa)
Ultimate Elongation (%) | min 21
min 700 | 30.0
806 |
| After Ageing : | | |
| Tensile Strength (MPa)
Ultimate Elongation (%) | min 16
min 500 | 28.1
801 |
| 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 exceeds 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 : 06 JUN 1996