RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

K994201 · Perusahaan Pelindung Getah (M) Sdn Bhd · LYY · Feb 7, 2000 · General Hospital

Device Facts

• Record ID: K994201
• Device Name: RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
• Applicant: Perusahaan Pelindung Getah (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Feb 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

The device is intended as a protective device to be worn on the hands of healthcare or similar personnel to prevent cross-contamination between the wearer and the person being examined. It may also be used in similar context during the handling of body fluids such as whole blood and plasma to protect the users from any risks of infections.

Device Story

Latex patient examination gloves; powder-free via chlorination process; chemical removal and acid neutralization steps; tack-free surface; intended for healthcare personnel; prevents cross-contamination; protects against infection during handling of body fluids; provides alternative for users sensitive to powdered gloves.

Clinical Evidence

Bench testing only. Data provided includes physical dimensions (length, width, thickness), tensile strength, ultimate elongation, water extractable protein content, water leak test (AQL), residual powder content, skin irritation, and dermal sensitization testing. All parameters met or exceeded ASTM D 3578-99 specifications.

Technological Characteristics

Latex material; powder-free via chlorination, chemical removal, and acid neutralization. Dimensions: 230mm min length, 0.08mm min thickness. Physical properties: 21 MPa min tensile strength, 700% min elongation. Protein content: 50 µg/g or less. Meets ASTM D 3578-99.

Indications for Use

Indicated for healthcare or similar personnel to prevent cross-contamination during patient examinations and handling of body fluids (e.g., blood, plasma).

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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PERUSAHAAN PELINDUNG GETAH (M) SDN BHD (Company No. 169997-P) Lot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Fax: [phone] Tel: [phone]

# 510(K) SUMMARY

K994201

| Applicant: | PERUSAHAAN PELINDUNG GETAH (M) SDN BHD |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Address | Lot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat<br>Senawang Industrial Estate, 70450 Seremban,<br>Negeri Sembilan, Malaysia. |
| Phone No. | 60-6-6772781 |
| Fax No. | 60-6-6772780 |
| Contact Person | Peter Yew Nieng Choon |
| Date of Summary | 18th November 1999 |

Device Information

| Trade Name | RUBBERCARE POWDER-FREE<br>LATEX EXAMINATION GLOVES WITH PROTEIN<br>LABELING CLAIM [50 MICROGRAMS OR LESS ]<br>GUARDIAN POWDER-FREE<br>LATEX EXAMINATION GLOVES WITH PROTEIN<br>LABELING CLAIM [50 MICROGRAMS OR LESS ] |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Powder-free Latex Exam Gloves |
| Classification Name | Patient Examination Gloves |

#### Claim of Equivalence

The device is a class II latex patient examination gloves 80LYY which is made powder-free by a process of chlorination and meets all the requirements of ASTM standard D 3578-99.

#### Device Description

It is the powder-free variation of the class II latex patient examination gloves made by washing the gloves in a chlorine solution followed by an effective chemical removal and acid neutralization steps. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive or allergic to the powdered version of the same gloves.

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Lot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Tel: [phone] Fax: [phone]

# Intended Use of Device

The device is intended as a protective device to be worn on the hands of healthcare or similar personnel to prevent cross-contamination between the wearer and the person being examined.

It may also be used in similar context during the handling of body fluids such as whole blood and plasma to protect the users from any risks of infections.

## Technological Characteristics

Following is a table showing the measured parameters of the gloves (e.g. lengths, thickness, widths, physical properties, protein contents, etc) as compared to ASTM. Also data that meets FDA biocompatibility, pinhole, powder-free and any other requirements, and any other parameter on which we want to make a labeling claim.

| Parameter | ASTM Specifications | Measured Values |
|--------------------------------------|---------------------|-----------------|
| Length, mm | 230 min. | 240 - 245 |
| Thickness (palm), mm | 0.08 min. | 0.14-0.16 |
| Thickness (finger), mm | 0.08 min. | 0.16-0.20 |
| Width (size M), mm | 95 ± 10 | 94 - 98 |
| Tensile Strength, Before Aging, Mpa | 21 min. | 24 - 32 |
| Tensile Strength, After Aging, Mpa | 16 min. | 20 – 28 |
| Ultimate Elongation, Before Aging, % | 700 min. | 800 - 900 |
| Ultimate Elongation, After Aging, % | 500 min. | 700 - 800 |
| Water Extractable Protein, µg per gm | n.a. | 50 and below |
| Water Leak Test, Before Aging, AQL | 2.5 | 1.5 and below |
| Water Leak Test, After Aging, AQL | 4.0 | 2.5 and below |
| Residual Powder (size M), mg | 2 mg/glove | 1 mg/glove |
| Skin Irritation Test | n.a | Passed* |
| Dermal Sensitization Test | n.a | Passed* |

* Please refers attachment L

# Conclusions

Based on the test data given above, we certify that our gloves:

- a. meet or exceed the ASTM standard D 3578-99
- b. meet the FDA pinhole requirements; and
- c. meet our labeling claim on protein content.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human figures, possibly representing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2000 FEB

Mr. Peter Yew Nieng Choon Managing Director of Perusahaan Pelindung Getah (M) Sdn. Bhd. Lot 110, Lorong Senawang 4/3 Off Jalan Senawang Empat Senawang Industrial Estate 70450 Seremban Neqeri Sembilan Darul Khusus, Malaysia

Re : K994201

Rubbercare Powder-Free, Guardian Powder-Free Trade Name: Latex Exam Gloves With Protein Labeling Claim (50 Micrograms or Less) Requlatory Class: I Product Code: LYY November 19, 1999 Dated: December 13, 1999 Received:

Dear Mr. Choon:

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 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 The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP

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Page 2 - Mr. Choon

requlation may result in regulatory action. In addition, FDA regulation may rebure in regulated oncerning your device in may publicit railer announce othis response to your ene release notification submission does not affect any premarker notification basmiser sections 531 through 542 of obligation you magne mare the Electronic Product Radiation the Act for devices andorher Federal laws or regulations.

This letter will allow you to begin marketing your device as first receir warr 510 k) premarket notification. The FDA described in your sio\n, promatence of your device to a legally finding of substancial equiralits in a classification for your marketed predicate as the 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 regulacion (ir c 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
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained from the Drvibion [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.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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## INDICATION FOR USE

| Applicant: | PERUSAHAAN PELINDUNG GETAH (M) SDN BHD |
|------------|----------------------------------------|
| 510(k) No. | K 994201 |

Powder-free Latex Examination Gloves with PlotEln LABELING Device Name:

#### Indications for Use

The device is intended as a protective device to be worn on the hands of healthcare or similar personnel to prevent cross-contamination between the wearer and the person being examined.

It may also be used in similar context during the handling of body fluids such as whole blood and plasma to protect the users from any risks of infections.

Chiu S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number