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

K962188 · Wembley Rubber Products (M) Sdn Bhd · LYY · Jul 26, 1996 · General Hospital

Device Facts

• Record ID: K962188
• Device Name: COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
• Applicant: Wembley Rubber Products (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jul 26, 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, low-protein, hypoallergenic latex patient examination glove. Used by healthcare and operating room personnel as a protective barrier to prevent contamination between the wearer and the patient's body, fluids, waste, or environment. Device functions as a 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 eliciting dermal irritation or sensitization, supporting the 'hypoallergenic' labeling claim.

Technological Characteristics

Latex patient examination glove; powder-free; low protein (<50 µg/g). Meets ASTM D3578-91 standards for dimensions, tensile strength, and ultimate elongation. Watertight integrity verified via 1000 ml test (AQL 2.5).

Indications for Use

Indicated for use by healthcare and operating room personnel as a protective barrier to prevent cross-contamination between personnel and patients.

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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WKP

CONTACT PERSON : MR. 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

K962188

JUL 26 1996

# 510 (K) SUMMARY

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

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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BS EN ISO 9002 : 1994

BRITISH STANDARDS INSTITUTION

REGISTRATION NO: FM 13934

GOOD MANUFACTURING PRACTICE

UK DEPARTMENT OF HEALTH

REGISTRATION NO: R0589/SP

REGISTERED

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 Blue Examination Gloves (Hypoallergenic, Low Protein) |
| --- | --- | --- |
| 1. Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 2.5 |
| 2. Length (mm) | | |
| Size | XS | - |
| | S | min 230 |
| | M | min 230 |
| | L | min 230 |
| | XL | - |
| 3. Palm width (mm) | | |
| Size | XS | - |
| | S | 80 ± 10 |
| | M | 95 ± 10 |
| | L | 111 ± 10 |
| | XL | - |
| 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 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 : May 27, 1996