(78 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.
Nitrile Powder Free Patient Examination Gloves, Now-Stern e Device Name
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets those criteria.
The document is a letter from the FDA to Seltom Pacific SDN. BHD. regarding the clearance of Nitrile Examination Gloves Powder Free (white) under K991776. It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
However, it does not contain any details about:
- Specific acceptance criteria for the gloves (e.g., tensile strength, barrier integrity, tear resistance).
- A study conducted to prove the device meets any such criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth was established.
The letter primarily focuses on the regulatory aspects of 510(k) clearance and general controls. The "Indications for Use" section simply describes the purpose of the medical glove.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three birds in flight, arranged in a stacked formation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
AUG 11 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. S. Seqaran Managing Director Seltom Pacific SDN. BHD. Lot 25 Jalan PJS 7/17 Sunway Industrial Park 46150 Petaling Jaya, Selanqor, Malaysia
RE: K991776 Trade Name: Nitrile Examination Gloves Powder Free (white) Requlatory Class: I Product Code: LZA Dated: June 28, 1999 Received: July 02, 1999
Dear Mr. Seqaran:
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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturinq 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) requlation (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 obliqation 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.
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Paqe 2 - Mr. Segaran
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 leqally 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 Additionally, for questions on the promotion and (301) 594-4692. advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 Other qeneral information on your responsibilities CFR 807.97). 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
i A. Ulatowsk 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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SELTOM PACIFIC
SELTOM PACIFIC SDN. BHD. (CO. NO. 256686-M) Lot 25, Jalan PJS 7/17, Sunway Industrial Park, 46150 Petaling Jaya, Selangor, Malaysia.
603-7356010 -5826010 603-7342713 -Mail: seltom@pd.jaring.my
INDICATIONS FOR USE
Applicant
SELTOM PACIFIC SDN BHD
510(k) Number
Nitrile Powder Free Patient Examination Gloves, Now-Stern e Device Name
Indications for Use:-
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
1991776
It is a single use disposable glove.
Chiu S. Lin
(Division Sign-Off) (Division Sign-Only)
Division of Dental, Infection Control, Division of Hospital D 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.