(83 days)
A patient examination glove is a disposable device intend for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
BLUE NITRILE EXAMINATION GLOVES, POWDER FREE.
The provided document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria, as it pertains to AI/ML or a more complex medical device. Instead, it confirms that the Nitrile Examination Gloves Powder Free (Blue Color) are substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the given text. The document is primarily an administrative letter about regulatory approval for a low-risk medical device (patient examination gloves).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized depiction of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of unity or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2002
Mr. Rajeev Kumar Sood President Innovative Glove Company Limited 500 Moo 4. T. Kuanlang A. Hatyai, Songkhla THAILAND
Re: K021668
Trade/Device Name: Nitrile Examination Gloves Powder Free (Blue Color) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: July 22, 2002 Received: July 24, 2002
Dear Mr. Sood:
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 of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Mr. Sood
You must comply with 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 requirements as set forth in 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 vours.
Polvora Cucurite flor
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a company logo with the text "บริษัท อินโนเวทีฟ โกลฟส์ จํากัด INNOVATIVE GLOVES CO.,LTD.". The logo features a stylized letter 'G' on the left side. The text is in both Thai and English, indicating the company's name and legal status.
tyai, Songkhla 90110. Tel : (66-74) 474730-2 Fax : (66-74) 474734 500 หม่ 4 ต.ควนลัง อ.หาดใหญ่ จ.สงขลา 90110. www.innovativegloves.net Emall : rsood@innovativegloves.net Mobile : (66-1) 9591891
510 (K) Number :- K 021668
Name of Applicant :- Innovative gloves Co. Ltd
Device Name:- BLUE NITRILE EXAMINATION GLOVES, POWDER FREE.
INDICATION FOR USE:
A patient examination glove is a disposable device intend for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_ (Optional Format 1-2-96)
Qiin S. Lin
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Denta
510(k) Number: K021668
Mjew ha a
§ 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.