NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES

• K Number: K041041
• Device Name: NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
• Manufacturer: SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.
• Date Cleared: 2004-06-08 ( 47 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 evan miner.

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 D5250-00 Ed

AI/ML Overview

The provided document is a 510(k) summary for the "Powder free Vinyl Examination" glove, detailing its substantial equivalence to a predicate device. It does not contain information about a study with specific acceptance criteria and detailed device performance metrics in the way that would typically be described for a diagnostic AI device.

However, based on the information provided, I can extract what is considered the "acceptance criteria" for regulatory clearance (substantial equivalence) and the "study" that supports it, even if it's not a quantitative clinical study with metrics like sensitivity, specificity, or AUC.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices seeking 510(k) clearance, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing technological characteristics, intended use, and safety/effectiveness.

Acceptance Criteria (for Substantial Equivalence to Predicate)	Reported Device Performance (Comparison to Predicate Device #K971415)
Technological Characteristics (e.g., design, materials, performance, sterility, biocompatibility, safety)	"Comparison result REFER TO ADDITIONAL TECHNICAL COMPARATIVE TABLE WITHIN 510K SUBMISSION" (Overall table states "Identical" or "Similar" for specific characteristics)
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 (Meets ASTM Standard D5250-00 Ed)
Electrical safety	Identical (not applicable)
Thermal safety	Identical (not applicable)
Radiation safety	Identical (not applicable)

2. Sample size used for the test set and the data provenance

The document describes a regulatory submission for a medical device (examination glove) claiming substantial equivalence to a previously cleared predicate device. This is not a study in the sense of collecting new performance data on a "test set" from patients or a specific dataset. Instead, the "test" is the comparison of the device's characteristics and performance against established standards and the predicate device.

• Sample size for the test set: Not applicable in the context of clinical data. The assessment is based on the device's design, materials, manufacturing processes, and compliance with standards. If physical testing (e.g., for tensile strength, barrier integrity) was performed, the sample sizes for those specific tests are not detailed in this summary.
• Data provenance: Not applicable. The "data" here refers to the device's specifications and comparison to the predicate, as well as adherence to standards like ASTM D5250-00 Ed. This is not clinical data from patients or a specific country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study involving expert-established ground truth for a diagnostic outcome. The "ground truth" for a medical glove's safety and effectiveness is established through compliance with recognized standards and demonstration of equivalent performance to predicate devices which have already been deemed safe and effective.

4. Adjudication method for the test set

Not applicable. There is no "test set" in the context of human interpretation or diagnostic outcomes requiring adjudication.

5. 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. This is a medical glove, not an AI-powered diagnostic device. No MRMC study or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's safety and effectiveness relies on:

• Compliance with recognized standards: Specifically, ASTM Standard D5250-00 Ed for Vinyl Patient Examination Gloves.
• Demonstrated equivalence to a predicate device: The predicate device (Shanghai Foremost Vinyl Patient Examination Glove, Powder free, 510(k) #K971415), which was previously cleared by the FDA, serves as the benchmark for safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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JUN =8 2004

SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.

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

SongHang County, Shanghai, 201611, PRC TEL: [phone] FAX: [phone] E-mail: [e-mail]

510 (k) Summary

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]
• Charyos Sincharoenkul (General Manager) 5. Contract Person:
• 6. Date summary prepared: December 10, 2002
• 7. Official Correspondent: Sempermed USA Inc.
• 30798 US Hwy. 19N 8. Address:
  • Palm Harbor, USA , FL 34684
• 727 787 7250 9. Phone:
• 727 787 7558 10. Fax:
• 11. Contact person: Mr. William E Harris
• 12. Device Trade or Proprietary Name: Powder free Viryl 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 880.6250, Powder free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00 Ed

• 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 panent and examiner
• 18. Safety and effectiveness of the device:
      This device is safe and effective as the predicate device Shanghal Foremost Vinyl Patient Examination Glove, Powder free, Indeed, it is equivalent This is better expressed in the tabulated comparison (Paragraph 19 below)

Page 3. 1

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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 Putient 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
TECHNOLOGICALCHARACTERISTICS	Comparison resultREFER TO ADDITIONAL TECHNICALCOMPARATIVE TABLE WITHIN 510KSUBMISSION
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)

Page 3.2

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three stylized human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN -8 2004

Shanghai Foremost Plastic Industrial Co., Ltd. C/O Mr. Ned Devine Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548-1289

Re: K041041

Ko-1041
Trade/Device Name: Non-Sterile Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: May 26, 2004 Received: May 28, 2004

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nate 10 row 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 Interstate commerce privers that have been reclassified in accordance with the provisions of Amendments, or to do roomsond Act (Act) that do not require approval of a premarket the Federal F 000; Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions over 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 Wri), it may be back of Federal Regulations, Title 21, Parts 800 to 898. In your device ear over way publish further announcements concerning your device in the Eederal Register.

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Page 2 - Mr. Devine

Please be advised that FDA's issuance of a substantial equivalence determination does not I total be act room a determination that your device complies with other requirements nioan that 1271 has music statutes and regulations administered by other Federal agencies. or the ret comply with all the Act's requirements, including, but not limited to: registration r od intist compry with a 807); labeling (21 CFR Part 801); good manufacturing practice and noting (2 = 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 promative next are 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), nlease 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,

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: [e-mail]

INDICATIONS FOR US

Applicant:

KO41041 510(k) Number:

Device Name: Non Sterile Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves

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 evan miner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Mulvey

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K04104

Page 1 of

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.