(19 days)
A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient
Powder-Free Nitrile Examination Glove, BLUE
This FDA 510(k) clearance letter and associated documents describe the approval of "Powder-Free Nitrile Examination Glove, Blue." This is a medical device approval, not an AI/ML device approval, and therefore the requested information regarding AI/ML device performance, study design, and ground truth establishment is not applicable.
The document indicates that the device is a "patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient."
Key points from the document regarding the device's regulatory pathway:
- Regulation Number: 880.6250
- Regulation Name: Patient Examination Gloves
- Regulatory Class: I (indicating lower risk, typically cleared via 510(k) processes without extensive clinical trials)
- Product Code: LZA
- Substantial Equivalence: The device was found substantially equivalent to legally marketed predicate devices, which is the primary basis for 510(k) clearance. This means it performs similarly to other gloves already on the market and has the same intended use.
Since this is a Class I device and the clearance is based on substantial equivalence to existing devices, the types of detailed performance studies and ground truth establishment typically required for AI/ML devices or higher-risk medical devices are not present or required in this submission. The acceptance criteria for such a device would generally relate to manufacturing standards, biocompatibility, and physical properties (e.g., tensile strength, barrier integrity) that are assessed through laboratory testing rather than human reader studies or large-scale clinical trials.
Therefore, the requested information cannot be provided as it pertains to a different type of medical device and regulatory pathway.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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MAY 14 2002
Food and Drug Administration. 9200 Corporate Boulevard Rockville MD 20850
Mr. Tan Peng Hock Glovco (M) Sdn. Bhd. Lot 760 ( Block A ), Jalan Haji Sirat, Off Jalan Meru Klang, Selangor D. E., MALAYSIA 42100
Re: K021308
Trade/Device Name: Powder-Free Nitrile Examination Glove, Blue Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: April 22, 2002 Received: April 25, 2002
Dear Mr. Hock:
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. Hock
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 yours,
Susan Runser
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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| PREMARKET NOTIFICATION [510(K)] FOR |
|---|
| POWDER-FREE NITRILE EXAMINATION GLOVES |
| Applicant | : GLOVCO (M) SDN BHD |
|---|---|
| Date | : April 16, 2002 |
INDICATION FOR USE . '3.0
510(K) Number (if known)
:
Device Name
Powder-Free Nitrile Examination Glove, BLUE
Indications For Use:
"A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare 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
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Stol Clin
ivition Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ACS
§ 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.