CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)

K972615 · Wembley Rubber Products (M) Sdn Bhd · LYY · Jan 26, 1999 · General Hospital

Device Facts

• Record ID: K972615
• Device Name: CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
• Applicant: Wembley Rubber Products (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jan 26, 1999
• 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 and similar personnel to prevent contamination between the healthcare or similar personnel and the chemotherapy agents and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Device Story

Chemo Plus Powder Free Blue Latex Examination Gloves are disposable latex gloves designed for healthcare personnel. Device acts as a physical barrier to prevent cross-contamination between the wearer and chemotherapy agents, patient body fluids, waste, or the environment. Used in clinical settings by healthcare professionals. Gloves are manufactured to meet ASTM D3578-91 standards for physical properties, including tensile strength and elongation, and are labeled for low protein content (below 50 micrograms/gram) to reduce potential for latex sensitivity. Output is a protective barrier; healthcare providers use the gloves during patient examinations or handling of chemotherapy agents to maintain sterile or clean conditions and protect against chemical exposure.

Clinical Evidence

Bench testing only. Performance data demonstrates compliance with ASTM D3578-91 requirements for watertightness (AQL 1.5), dimensions, and physical properties (tensile strength and ultimate elongation before/after aging). Protein content verified below 50 micrograms/gram using ASTM D5712.

Technological Characteristics

Latex patient examination glove; powder-free; blue color. Meets ASTM D3578-91 standards for physical dimensions, tensile strength (min 21 MPa before aging), and ultimate elongation (min 700% before aging). Protein content < 50 micrograms/gram. Moisture content < 0.8%. Powder content < 2 mg/glove.

Indications for Use

Indicated for use by healthcare personnel as a specialty medical glove to prevent contamination between the examiner and chemotherapy agents, and to prevent contamination between the examiner 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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972615

# WEMBLEY RUBBER PRODUCTS (M) SDN BHD (No: 147817-V)

l.ot 1, Jalan 3, Kawasan Perusahaan Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, Malaysia nrketing / QA Tel: [phone] / 1867 Fax: [phone] / 1557 Operations Tel: [phone] / 1496 Fax: [phone] / 1608

CONTACT PERSON : MR. Y. W. CHOW

### 510 (K) SUMMARY

1. Trade Name : CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)

- 2. Common Name : Examination Gloves
- 3. Classification Name : Patient Examination Glove

#### 4. Substantial Equivalence :

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

#### 5. Description of device :

Class I latex patient examination glove 80 LZC, powder free, protein content labeling, 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 and similar personnel to prevent contamination between the healthcare or similar personnel and the chemotherapy agents and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

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Image /page/0/Picture/18 description: The image is a black and white circular logo. The logo contains the words "REGISTERED FIRM" around the outside of the circle. Inside the circle is a downward-pointing triangle above a heart shape. Above the circle is a symbol that looks like a crown.

Image /page/0/Picture/19 description: The image shows a logo with the word "REGISTERED" in a white oval shape, placed on top of a black diamond shape. Below the diamond, there is text that reads "MS ISO 9002 : 1994". The logo appears to be a certification mark, possibly indicating compliance with the MS ISO 9002 standard from 1994.

Image /page/0/Picture/20 description: The image shows the CE marking, a symbol used to indicate conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. The marking consists of the letters "CE" in a specific font and layout. Below the CE marking, the text "COUNCIL DIRECTIVE 93/42/EEC" is visible, indicating the specific directive related to medical devices.

EN 16001 (1002) AND EN 20001 (1007)

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## 7. Summary of Performance data :

:

92615

| TEST | ASTM D 3578-91 | CHEMO PLUS Powder Free<br>Blue Latex Examination<br>Gloves (Protein Content<br>Labeling) |
|---------------------------------------------------|------------------------------------------------------|------------------------------------------------------------------------------------------|
| 1. Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 1.5 |
| 2. Length (mm) | | |
| Size<br>XS<br>S<br>M<br>L<br>XL | -<br>min 230<br>min 230<br>min 230<br>- | -<br>292<br>304<br>308<br>- |
| 3. Palm width (mm) | | |
| Size<br>XS<br>S<br>M<br>L<br>XL | -<br>$80 \pm 10$<br>$95 \pm 10$<br>$111 \pm 10$<br>- | -<br>83<br>95<br>106<br>- |
| 4. Thickness (mm) | | |
| Finger<br>Palm | min 0.08<br>min 0.08 | 0.46<br>0.27 |
| 5. Physical Properties | | |
| Before Ageing : | | |
| Tensile Strength (MPa)<br>Ultimate Elongation (%) | min 21<br>min 700 | 30.78<br>839 |
| After Ageing : | | |
| Tensile Strength (MPa)<br>Ultimate Elongation (%) | min 16<br>min 500 | 27.41<br>845 |
| 6.Powder Content | - | below 2 mg / glove |
| 7. Moisture Content | - | max 0.8% / glove |
| 8. Protein Content | - | below 50 microgram / gram |

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

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K972615

## 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. Conclusion

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

Date Summary Prepared : June 17, 1997

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 26 1999

Mr. Chow Yue Wah Vice President QA/RA Wembley Rubber Products (M) Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

K972615 Re : Chemo Plus Powder-Free Blue Latex Trade Name: Examination Gloves (Protein Labeling Claim 50 Micrograms or Less) Regulatory Class: I Product Code: LYY November 10, 1998 Dated: November 17, 1998 Received:

Dear Mr. Chow Yue Wah:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Chow Yue Wah

through 542 of the Act for devices under the Electronic chrough 342 or eno notrol provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acinding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmama/n.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known) : _ K972615

# Device Name : CHEMO PLUS POWDER FREE BLUE LATEX EAMINATION GLOVES (PROTEIN CONTENT LABELING) 50 MICROGRAMS OR LESS

### Indications For Use :

- 1. The chemotherapy examination glove is a specialty medical glove which is a The onemedial device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

:

Over-The-Counter Use OR

Qlin S. Lin
(Division Sign-Off)

Division of Dental, Infection Control,
Division of Dental, Infection Control, and General Hospital, Infect 510(k) Number