LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)

K992018 · La Glove (M) Sdn. Bhd. · KGO · Jul 30, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992018
• Device Name: LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
• Applicant: La Glove (M) Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jul 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 ugm or less of water extractable protein per gram is a disposable glove made of Natural Rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Disposable sterile powdered latex surgical gloves; intended for use by operating room personnel; primary function is protection of surgical wounds from contamination; device features reduced protein content labeling claim (150 micrograms or less of water-extractable protein per gram).

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Natural rubber latex. Form factor: Sterile, powdered surgical glove. Feature: Water-extractable protein content limited to 150 µg/g or less.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. Disposable device made of natural rubber.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Mr. G. Baskaran Managing Director LAGLOVE (M) SDN. BHD. Lot 478, Jalan Simpang Balak Off Batu 13, Jalan Cheras 43000 Kajang, Selangor Darul Ehsan MALAYSIA

K992018 Re:

> LAGLOVE™ Powdered Latex Surgical Gloves Trade Name: With Protein Content Labeling Claim (150 Micrograms Or Less) I Requlatory Class: Product Code: KGO Dated: June 11, 1999 Received: June 16, 1999

Dear Mr. Baskaran:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marker 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 Requlations, Title 21, Parts 800 to 895. ਬੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action.

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Page 2 - Mr. Baskaran

In addition, FDA may publish further announcements concerning your device in the Federal Register.

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control 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 finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Timothy W. 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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## K992018

## Indications for use 3.0

| Applicant | : LAGLOVE (M) SDN. BHD. |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | : |
| Device name | : LAGLOVE™ Brand Latex Surgical<br>Gloves - Sterile (Powdered)<br>Containing 150 µgm or less of water<br>Extractable protein per gram. |

Indications for use:

LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 ugm or less of water extractable protein per gram is a disposable glove made of Natural Rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Claus S. Lim

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

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use\$\times\$

(Optional Format 1-2-96)

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