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

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

Predicate Devices

K971415

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a standard patient examination glove and makes no mention of AI or ML technology.

Therapeutic

No.
The device is a patient examination glove, intended to prevent contamination, not to provide therapy or treatment to a patient.

Diagnostic

No
The device is a patient examination glove, which is used for contamination prevention during examination, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly identifies the device as a physical patient examination glove, which is a hardware device. There is no mention of software functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to prevent contamination between the patient and the examiner by being worn on the hand. This is a physical barrier function, not a diagnostic test performed on a sample from the body.
• Device Description: It's classified as a Class I device under 21 CFR 880.6250, which is for patient examination gloves. IVDs typically fall under different classifications and regulations related to diagnostic testing.
• Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
  • Analyzing a sample (blood, urine, tissue, etc.)
  • Detecting a specific analyte or condition
  • Providing diagnostic information

Therefore, this device is a medical device used for barrier protection, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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.

Product codes (comma separated list FDA assigned to the subject device)

80LYZ, LYZ

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K971415

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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
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)

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.

3

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

4

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

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