(33 days)
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient." [50 Microgram or less Protein labeling Claim]
Polymer Coated Powder Free Latex Examination Gloves
This document is a 510(k) premarket notification letter from the FDA regarding "Latex Examination Gloves (50 mcg or less protein labeling claim)". It concerns the regulatory approval of a medical device, which is a type of glove, and does not involve AI or an algorithm. Therefore, none of the requested information about AI device acceptance criteria, study data, ground truth, or MRMC studies is applicable to this document.
The document primarily states that the device is substantially equivalent to legally marketed devices and can be marketed subject to general controls. It details the product name, applicant, 510(k) number, and indications for use, which are as follows:
Indications For Use: "A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient." with a "[50 Microgram or less Protein labeling Claim]".
The document does not contain information on device performance metrics, study designs, sample sizes, or expert qualifications as it is a regulatory approval letter based on substantial equivalence, not a performance study report for an AI device.
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Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized depiction of an eagle or bird in flight, with three distinct wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 1999
Mr. Stanley Thai Managing Director Supermax Glove Manufacturing Sdn. Bhd. Lot 42, Putra Industrial Park, Bukit Rahman Putra, 47000 Sunqai Buloh, Selangor Darul Ehsan MALAYSIA
Re: K991415 Superqloves, Polymer Coated Powder Free Trade Name: Latex Examination Gloves (50 mcg or less protein labeling claim) Requlatory Class: I Product Code: LYY Dated: April 19, 1999 Received: April 23, 1999
Dear Mr. Thai:
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 reguirements for annual registration, listing of devices, qood 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 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Paqe 2 - Mr. Thai
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 requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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,
Susan Turner
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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INDICATIONS FOR USE
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| Applicant: | Supermax Glove Manufacturing Sdn Bhd |
|---|---|
| 510(k) Number (if known) : | K991415 |
| Device Name : | Polymer Coated Powder Free Latex Examination Gloves |
| Indications For Use : | [50 Microgram or less Protein labeling Claim] |
"A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel 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 801.109 | OR | Over-The-Counter X |
|---|---|---|
| ------------------------------------- | ---- | -------------------------------------------------------------------- |
(Optional Format 1-2-96)
| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number | K991415 |
|---|---|
| ------------------------------------------------------------------------------------------------------- | --------- |
§ 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.