(50 days)
LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powder Free) containing 50 µgm 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.
LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powder Free) Containing 50 ugm or less of water Extractable protein per gram.
This document is a 510(k) premarket notification approval letter from the FDA for Laglove™ Powder Free Latex Surgical Gloves. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a clinical study report for an AI/ML device would.
The letter approves the device for marketing based on "substantial equivalence" to a predicate device. This means the FDA has determined the new device is as safe and effective as a legally marketed device. The "indications for use" (page 2) describe the intended purpose of the gloves, but these are not performance acceptance criteria.
Therefore, I cannot provide the requested information from this document. To answer your questions, I would need a different type of document, such as a study report or a technical performance specification for an AI/ML device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG -5 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 : K992019
Laglove™ Powder Free Latex Surqical Gloves Trade Name: With Protein Content Labeling Claim (50 Micrograms or Less) Requlatory Class: I Product Code: KGO June 11, 1999 Dated: 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 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਉ 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
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Page 2 - Mr. Baskaran
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 findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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) 638-2041 or (301) 443-6597 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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3.0 Indications for use
Applicant 510(k) number Device name
: LAGLOVE (M) SDN. BHD.
: LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powder Free) Containing 50 ugm or less of water Extractable protein per gram.
Indications for use:
510(k) Number
LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powder Free) containing 50 µgm 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)
| Prescription Use_ | OR | Over-The-Counter Use X |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
§ 878.4460 Non-powdered surgeon's glove.
(a)
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.(b)
Classification. Class I (general controls).