POWDER FREE VINYL EXAMINATION GLOVE

• K Number: K032071
• Device Name: POWDER FREE VINYL EXAMINATION GLOVE
• Manufacturer: SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.
• Date Cleared: 2003-10-10 ( 99 days)
• Product Code: LYZ
• Regulation Number: 880.6250
• Type: Abbreviated
• Panel: General Hospital
• Reference & Predicate Devices: k971415
• Predicate For: N/A

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Device Description

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 380,6250. Powder free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00 E4

AI/ML Overview

The provided text describes a 510(k) summary for a "Powder free Vinyl Examination Glove" and focuses on establishing its substantial equivalence to a predicate device, rather than presenting a study demonstrating acceptance criteria met by the device itself in a typical AI/software context.

Therefore, many of the requested fields are not applicable to this type of submission. However, I will extract the available information and indicate where specifics about a performance study are missing.

Analysis of the Document for AI/Software Device Acceptance Criteria and Study:

The document describes a medical device, specifically a "Powder free Vinyl Examination Glove." This is a physical, disposable medical device, not an AI or software device. As such, the concept of "acceptance criteria" and "study" in the context of AI performance (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies, training/test sets) does not directly apply.

Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device (Shanghai Foremost Vinyl Patient Examination Glove, Powder free, 510(k) #K971415). This is a regulatory pathway for Class I and Class II devices in the US, where the new device is shown to be as safe and effective as a legally marketed device.

Table of Acceptance Criteria and Reported Device Performance (as translated for a physical device and substantial equivalence):

Acceptance Criteria (for Substantial Equivalence to Predicate)	Reported Device Performance (Claimed Equivalence)
Indications for use: Identical to predicate	Identical
Target population: Identical to predicate	Identical
Design: Similar to predicate	Similar
Materials: Similar to predicate	Similar
Performance: Identical to predicate (meets ASTM Standard D5250-00 E4)	Identical (meets ASTM Standard D5250-00 E4)
Sterility: Identical to predicate	Identical
Biocompatibility: Identical to predicate	Identical
Mechanical safety: Identical to predicate	Identical
Chemical safety: Identical to predicate	Identical
Anatomical sites: Identical to predicate	Identical
Human factors: Identical to predicate	Identical
Energy used and/or delivered: Not applicable to predicate	Identical (Not applicable)
Compatibility with environment and other devices: Identical to predicate	Identical
Where used: Identical to predicate	Identical
Standards met: Identical to predicate	Identical
Electrical safety: Not applicable to predicate	Identical (not applicable)
Thermal safety: Not applicable to predicate	Identical (not applicable)
Radiation safety: Not applicable to predicate	Identical (not applicable)

Missing Information (Not applicable to this type of device/submission):

The following information is primarily relevant for AI/software-based medical devices and is therefore not found in this 510(k) submission for a physical glove:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical glove. Performance is typically assessed through physical testing (e.g., tensile strength, puncture resistance, barrier integrity) against established standards (like ASTM D5250-00 E4) rather than data from a test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like a glove involves objective measurements and compliance with material standards, not expert interpretation of data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical glove, the "ground truth" would be objective measurements against an engineering standard (e.g., ASTM D5250-00 E4), not expert consensus or pathology.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (examination glove) seeking substantial equivalence to a predicate device. It demonstrates performance by claiming adherence to an ASTM standard and direct comparison of characteristics to a previously cleared device, not through an AI-style performance study with test sets, ground truths, or expert evaluations.

Summary

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SHANGHAL FOREMOST PLASTIC INDUSTRIAL CO., LTD.

Yan Li River Bridge East, Che Xing Highway, Che Dun Town,

Songjiang County, Shanghai, 201611, PRC

TEL: [phone] FAX: [phone] E-mail: [e-mail]

OCT 1 0 2003

510 (k) Summary

Ko 32071

As Required by 21 section 807.92 ( c)

• 1. Submitter Name: Shanghai Foremost Plastic Industrial Co. ,Ltd.
• 2. Address: Yan Li River Bridge East, Che Xing Highway, Che Dun Town, Songjiang County, Shanghai,201611, PRC
• 3. Phone: [phone]
• 4. Fax: [phone]
• Chaiyos Sincharoenkul (General Manager) 5. Contract Person:
• 6. Date summary prepared: December 10, 2002
• 7. Official Correspondent: Sempermed USA Inc.
• 30798 US Hwv. 19N 8. Address:
  • Palm Harbor, USA , FL 34684
• 9. Phone: [phone]
• 10. Fax: [phone]
• 11. Contact person: Mr. William E Harris
• 12. Device Trade or Proprietary Name: Powder free Vinyl Examination
• 13. Device Common or usual name: Examination glove
• 14. Device Classification Name: Glove , Patient Examination , Vinyl
• 15. Substantial Equivalency is claimed against the following device : Shanghai Foremost Vinyl Patient Examination Glove, Powder free, 510(k) #K971415 (refer to Appendix 1 for FDA website printout) This notification for the Powder free Vinyl Examination glove is of the ABBREVIATED type as per the declaration of conformity on page B2 of this summary
• 16. Description of the Device:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 380,6250. Powder free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00 E4

• 17. Intended use of the device:
      This device is a disposable device intended for medical purpose that is worn on the examiner 's hand to prevent contamination between patient and examiner
• 18. Safety and effectiveness of the device:
      This device is safe and effective as the predicate device Shanghai Foremost Vinyl Patient Examination Glove, Powder free, Indeed, it is equivalent This is better expressed in the tabulated comparison (Paragraph 19 below)

Image /page/0/Picture/31 description: The image displays the word "CONFIDENTIAL" in bold, uppercase letters. The font appears to be a sans-serif typeface, and the letters are closely spaced. The image has a slightly grainy texture, suggesting it may be a scan or a copy of an original document.

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• 19. Summary comparing technological characteristics with other predicate device: General comparison result between Powder free Vinyl Examination and predicate device (Shanghai Foremost Vinyl Patient Examination Glove, Powder free) is tabulated below.
      Technical comparison of specific elements is attached in the main submission.

FDA file reference number	510k Number: K971415
Attachments inside notification submission file	REFER TO APPENDIX 1
TECHNOLOGICAL CHARACTERISTICS	Comparison result
	REFER TO ADDITIONAL TECHNICAL COMPARATIVE TABLE WITHIN 510K SUBMISSION
Indications for use	Identical
Target population	Identical
Design	Similar
Materials	Similar
Performance	Identical
Sterility	Identical
Biocompatibility	Identical
Mechanical safety	Identical
Chemical safety	Identical
Anatomical sites	Identical
Human factors	Identical
Energy used and/or delivered	Identical (Not applicable)
Compatibility with environment and other devices	Identical
Where used	Identical
Standards met	Identical
Electrical safety	Identical (not applicable)
Thermal safety	Identical (not applicable)
Radiation safety	Identical (not applicable)

Image /page/1/Picture/5 description: The image contains the word "CONFIDENTIAL" in bold, black letters. The word is slightly tilted upwards from left to right. The background is white, providing a strong contrast to the text.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circle with the words "HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2003

Shanghai Foremost Plastic Industrial Co., Ltd C/O Mr. Ned Devine, Jr. Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K032071

Trade/Device Name: Powder Free Vinyl Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: October 6, 2003 Received: October 8, 2003

Dear Mr. Devine:

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.

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Page 2 -- Mr. Devine

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 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), please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Quris

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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SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.

Yan Li River Bridge East, Che Xing Highway, Che Dun Town,

Songjiang County, Shanghai, 201611, PRC

TEL: [phone] FAX: [phone] E-mail: shaforemost@online sh.cn

INDICATIONS FOR USE

Applicant: Shanghai Foremost Plastic Industrial Co. ,Ltd. 622071 510(k) Number:

Device Name: Powder free Vinyl Examination Glove

Indications for Use:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Oat Ang. de Onn. 10/10/03
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number:________________________________________________________________________________________________________________________________________________________________ R 032071

Page C3

Regulation Number and Section

§ 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.