(36 days)
A patient examination glove that is worn by the healthcare or similar personnel to prever t contamination setween the healthcare and the patient.
Powdered Latex Examination Gloves with Protein Labeling Claim
The provided document is a 510(k) clearance letter from the FDA for "Latex Examination Gloves Powdered, with Trade Name: Protein Labeling Claim (50 Micrograms or Less Per Gram)". This document is a regulatory approval and does not contain the acceptance criteria or a study proving the device meets the acceptance criteria for an AI/ML powered device.
The letter states that the device is "substantially equivalent" to predicate devices, meaning it has similar indications for use, safety, and effectiveness. However, it does not detail specific performance metrics, sample sizes, expert ground truth, or study designs that would be relevant for evaluating an AI/ML diagnostic or screening device.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria based on the input document. The input relates to the regulatory approval of a physical medical device (gloves), not an AI/ML software device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 4 1999
Mr. Tan Peng Hock Glovco (M) Sdn. Bhd. Lot 760, (Block A) Jalan Haji Sirat, Off Jalan Meru, 42100 Klanq, Selangor Darul Ehsan, MALAYSIA
Re : K991043 Latex Examination Gloves Powdered, with Trade Name: Protein Labeling Claim (50 Micrograms or Less Per Gram) Regulatory Class: I Product Code: LYY Dated: March 19, 1999 March 29 1999 Received:
Dear Mr. Tan Peng Hock:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਖੇ 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Tan Peng Hock
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 (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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510(k) Number (if known): K 991043
Device Name: Powdered Latex Examination Gloves with Protein Labeling Claim
Indications For Use:
" A patient examination glove that is worn by the healthcare or similar personnel to prever t contamination setween the healthcare and the patient".
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 8()1.109) OR
Over-The-Counter Use X
(Optional fromat 1-2-96)
Chin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.