(86 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A 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.
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Powder-free Vinyl Patient Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.
This is a 510(k) premarket notification for "SHANGHAI COSMOS CORP. Powder-free Vinyl Patient Examination Gloves". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study following the user's specific request for AI/ML device testing criteria. Therefore, most of the requested information regarding AI/ML device performance and study design cannot be extracted from this document, as it is not relevant to a glove 510(k) submission.
However, I can provide information based on the typical requirements for patient examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM D5250-92) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (AQL 4.0, Inspection Level S-2) | Met requirements |
| Pinhole FDA Requirements (AQL 2.5, Inspection Level S-4, 1000 ml Water Fill Test) | Met requirements |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions |
| Powder-free claim (USP Iodine Test for Starch & Particulate testing) | Met (powder-free claim adhered to, particulate testing contracted) |
| Biocompatibility requirements | Met requirements (implied by skin irritation/sensitization tests) |
| Labeling claims | Met requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "samplings of AQL 2.5, Inspection Level S-4" for the FDA 1000 ml. Water Fill Test and "Inspection Level S-2, AQL 4.0" for Physical and Dimensions Testing. The specific sample sizes for these AQL (Acceptable Quality Level) levels would be determined by the standard ASTM D5250-92 and the batch size of the gloves, but the exact number is not explicitly stated in this summary.
Data Provenance: Not applicable for this type of product as it's not data-driven in the way an AI/ML device would be. The testing is performed on the manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for glove performance is established by the specified ASTM standards and FDA requirements, not by expert consensus on interpretations.
4. Adjudication Method for the Test Set
Not applicable. Physical and chemical tests are objective and do not typically involve adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is not an AI/ML device, and an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This refers to an AI/ML device, which this product is not.
7. The Type of Ground Truth Used
The ground truth is based on:
- ASTM D-5250-92 standards for physical properties and dimensions.
- FDA pinhole requirements (1000 ml water fill test).
- Results from biocompatibility tests (primary skin irritation and sensitization).
- USP Iodine Test methodology for powder-free claims.
8. The Sample Size for the Training Set
Not applicable. This is a non-AI/ML device.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is a non-AI/ML device.
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SHANGHAI CUSMUS
NO.1. RONG XING ROAD, CHE DUN ZHEN, SONG JIANG COUNTY, CHINA SHANGHAT .. C/O: 11F, 201, NANKING E. RD., SEC. 3, TAIPEI, TAIWAN, R.O.C TEL/FAX: 886-2-25462480
OCT 1 1999
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
The assigned 510(k) number is: K992227 2
1.Submitter's Identification:
Ms. CHIAN-LI HUNG de LEE SHANGHAI COSMOS CORP. No. 1. Rong Xing Road, Che Dun Zhen, Song Jiang County Shanghai, China
Date Summary Prepared: 25 May 1999
2. Name of the Device:
SHANGHAI COSMOS CORP. Powder-free Vinyl Patient Examination Gloves
3. Predicate Device Information:
Shanghai Super Gloves Co., Ltd. #K974120
4. Device Description:
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Powder-free Vinyl Patient Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.
5. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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MANGHAI CUSMU NO.1. RONG XING ROAD, CHE DUN ZHEN, SONG JIANG COUNTY CHINA C/O: 11F. 201, NANKING E. RD., SEC. 3, TAIPEI, TAIWAN, TEL/FAX: 886-2-25462480
6. Comparison to Predicate devices:
SHANGHAI COSMOS CORP. Powder-free Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shanghai Super Gloves Co., Ltd. Powder-free vinyl patient examination Gloves.
7, Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for SHANGHAI COSMOS CORP. Production are based on ASTM D-5250-92. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
A USP Iodine Test for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free" claim. We adhere to all USP Iodine Test methodology and testing "powderresidue by weight" and are contracting with a laboratory to conduct particulate testing for added assurance. Final release testing consists of a light transmission test using a spectrophotometer.
8. Discussion of Clinical Tests Performed:
Not Applicable - There is not hypoallergenic claim.
9.Conclusions:
SHANGHAI COSMOS CORP. Vinyl Patient Examination Gloves conform fully to ASTM D-5250-92 standards as well as applicable 21 CFR references, and meets pinhole FDA requirements, bio-compatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the " substantial equivalence" products cited.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes, creating a sense of unity and connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1999 OCT
Shanghai Cosmos Corporation C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 410 Great Neck, New York 11021
K992272 Re : Powder-Free Vinyl Patient Examination Trade Name: Gloves Regulatory Class: I Product Code: LYZ Dated: July 2, 1999 Received: July 7, 1999
Dear Ms. Goldstein-Falk:
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 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Ms. Goldstein-Falk
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT A
Page -1 of of 1
510(k) Number (if known): _K 99 J372
SHANGHAI COSMOS CORP. Device Name: Powder-Free Vinyl Patient Examination Gloves
Indications For Use:
A 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clins. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.