(51 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Disposable Powdered Vinyl Examination Gloves
The provided document is a 510(k) premarket notification letter from the FDA for "Disposable Powdered Vinyl Examination Gloves". This type of document is for a medical device that demonstrates substantial equivalence to a legally marketed predicate device, rather than a novel AI/ML-driven diagnostic device.
Therefore, the specific information requested in the prompt about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable to this document. The FDA's determination for this device is based on demonstrating substantial equivalence to a predicate device, as outlined in the letter, rather than a clinical study with detailed performance metrics as would be required for an AI/ML diagnostic.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 4 2001
Shijiazhuang Brilliance Plastic Company Limited C/O Mr. Huan Chung-Li Vice President Shinemound Enterprise, Incorporated 17A Sterling Road North Billerica, Massachusetts 01862
Re: K012710
Trade/Device Name: Disposable Powdered Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: June 8, 2001 Received: August 14, 2001
Dear Mr. Chung-Li:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements
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Page 2 - Mr. Chung-Li
of the Act or any Federal statutes and regulations administered by other Federal agencies. or use or any - outh all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (21 CF t t t t t t t t t t t the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/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
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Attachment G
INDICATION FOR USE
Feng Lian Fa, Shijiazhuang Brilliance Plastic Co., LTD Applicant:
- KO12710 510K. Number (if known):
Device Name: Prepowdered Vinvl Patient Examination Gloves Indication For Use:
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Sincerely yours,
拮联法
Feng Lian Fa President
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| -------------------------------------------------------- |
Olin S. Lin
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K012710 |
| Prescription UsePer 21 CFR 801.109(Optional Format 1-2-96) | OR | Over-The Counter Use |
|---|---|---|
| -------------------------------------------------------------------- | ---- | ---------------------- |
- For a new submission, do NOT fill in the 510(K) number blank
§ 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.