(99 days)
A patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Vinyl Examination Gloves, Powdered
This document is a 510(k) premarket notification for Vinyl Examination Gloves, Powdered. It is a clearance letter from the FDA. This type of document, particularly for a Class I device like examination gloves, does not typically include detailed studies with acceptance criteria, sample sizes, expert ground truth, or adjudication methods in the same way a software device submission would.
Medical gloves are considered a low-risk device and their substantial equivalence is primarily based on performance standards and material specifications, rather than complex clinical studies or AI algorithm performance.
Therefore, I cannot provide the requested information because it is not present in the provided document and is generally not applicable to the FDA clearance process for a device of this type.
Here’s why the requested information isn't available for this document:
- Acceptance Criteria & Device Performance: For gloves, the acceptance criteria are typically related to physical properties (tensile strength, elongation, freedom from holes) and chemical safety (biocompatibility). The document mentions the device but does not provide a table of these performance metrics.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These are concepts primarily relevant to diagnostic algorithms, AI, or higher-risk devices requiring clinical trials, not basic medical devices like examination gloves. The document confirms substantial equivalence to a predicate device, which means direct comparative testing might have been done for certain physical properties, but not in the format of a "study" with AI or human readers.
- Ground Truth: For gloves, the "ground truth" would be objective measurements of their physical properties and sterility/biocompatibility, not an expert consensus on a diagnosis.
- Training Set: There is no "training set" for a physical device like a glove. This concept applies to machine learning algorithms.
In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence for a low-risk medical device (vinyl examination gloves). The detailed study information requested is not part of this type of submission for this particular device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2004
Ms. Iris Yang Sales Manager Shijiazhuang Wally Plastics Company, Limited No. 78 Tongda Road Jinzhou City, Hebei, CHINA 052260
Re: K041379
Trade/Device Name: Vinyl Examination Gloves, Powdered Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: June 25, 2004 Received: July 9, 2004
Dear Ms. Yang:
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 Amerate ents, 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 approvisions 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 (1 Writ), It har 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.
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Page 2 - Ms. Yang
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. 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 roquicable, 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), n you contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Chiu-Ling, Ph.D.
Chiu Lin, Ph.D. 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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INDICATION FOR USE
| Applicant: | SHIJIAZHUANG WALLY PLASTIC CO., LTD. |
|---|---|
| 510(k) Number (if known): | K041379 |
| Device Name: | Vinyl Examination Gloves, Powdered |
| Indication For Use: |
A patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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 |
| Ken Muly (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| -3- | 510(k) Number: K041379 |
| -3- | 510(k) |
|---|---|
| ----- | -------- |
§ 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.