LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)

K991950 · La Glove (M) Sdn. Bhd. · KGO · Aug 12, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991950
• Device Name: LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)
• Applicant: La Glove (M) Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Aug 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powder-Free) is a LAGLOVE™ Brand Nitrile Surgical Gloves intended to be worn by operating personnel to protect a surgical wound from contamination and other contaminants.

Device Story

Disposable sterile surgical glove made of synthetic nitrile rubber; intended for use by operating room personnel; provides barrier protection against contaminants; worn during surgical procedures to protect patient and clinician; single-use device.

Clinical Evidence

No clinical data provided; device relies on established material properties and regulatory compliance for surgical gloves.

Technological Characteristics

Material: Synthetic nitrile rubber. Form factor: Disposable surgical glove. Sterilization: Sterile. Powder-free. Class I medical device.

Indications for Use

Indicated for use by operating personnel as a disposable synthetic rubber glove to protect surgical wounds from contamination.

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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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of three stylized human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1:2 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

Re : K991950 Laglove™ Brand Nitrile Surgical Glove-Trade Name: Sterile (Powder-Free) Regulatory Class: I Product Code: KGO Dated: May 28, 1999 Received: June 9, 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 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, Druq, 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. A 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. In addition, FDA may publish further announcements 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 through 542 of

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Page 2 - Mr. Baskaran

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 asbellence for portantial 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 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" (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 (800) 638-204% or [phone] or at its internet address "http://www.fda/.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

A. 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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BRIGHTWAY HOLDING SDN BHD 15:32 08-10-99 Fax : [phone] un 12:04 FAX [phone] FDA/QDE/DDIGD ID=603+3414800

Jan 17 '93 06:45

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510(k) Number (if known): K 991950

Dovice Namo: Nitrite Surgical

## Indications For Use:

LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powder-Free) is a LAGLOVE'''' Brand Nittle Surgical Gloves intended to be worn by operating disposable glove made of synthelic rubber intendou'ts be works your learly and interials and other contaminants.

G.Baskaran

Managing Director. 10th August 99.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | |
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| <img alt="Signature" src="signature.png"/> | | | | |
| (Division Sign-Off) | | | | |
| Division of Dental, Infection Control, | | | | |
| and General Hospital Devices | | | | |
| 510(k) Number | 991950 | | | |

Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use X

(Optional Format 1-2-96)

18-99 08:24 RECEIVED FROM: 6038367455 P.03

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