VINYL PATIENT EXAMINATION GLOVE, POWDERED

• K Number: K971423
• Device Name: VINYL PATIENT EXAMINATION GLOVE, POWDERED
• Manufacturer: SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.
• Date Cleared: 1997-05-23 ( 36 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 examiner's 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, CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, powdered with an absorbable dusting starch powder, USP, Class III and conform to all requirements of ASTM Standard D5250-92 and FDA 1000 ml water leak test.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and safety of a patient examination glove, with no mention of AI or ML.

Therapeutic

No
A patient examination glove is intended to prevent contamination between patient and examiner, not to provide therapy.

Diagnostic

No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device is a physical patient examination glove, not a software application.

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 clearly states the device 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." This describes a barrier device used during physical examination, not a device used to examine specimens derived from the human body for diagnostic purposes.
• Device Description: The description focuses on the material (vinyl), classification (Class I), and performance standards related to physical properties (ASTM D5250-92, water leak test). It does not mention any components or functions related to analyzing biological samples.
• Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological specimens (blood, urine, tissue, etc.)
  • Detecting or measuring substances in biological samples
  • Providing diagnostic information about a patient's health status
  • Mentioning reagents, assays, or analytical methods

In summary, the device is a physical barrier for infection control during patient examination, which falls outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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

LYZ

Device Description

Classified by FDA's General and Plastic Surgery Device Panel as Class I, CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, powdered with an absorbable dusting starch powder, USP, Class III and conform to all requirements of ASTM Standard D5250-92 and FDA 1000 ml water leak test.

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)

Non-Clinical Performance data
Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000 ml water leak test for pin-holes.
Test: Length (mm)
Size S: Min. 230 mm (ASTM D5250-92), 240 ± 5 mm (Applicant Device)
Size M: Min. 230 mm (ASTM D5250-92), 240 ± 5 mm (Applicant Device)
Size L: Min. 230 mm (ASTM D5250-92), 240 ± 5 mm (Applicant Device)
Size XL: Min. 230 mm (ASTM D5250-92), 240 ± 5 mm (Applicant Device)
Test: Width (mm)
Size S: 85 ± 5 mm (ASTM D5250-92), 87 ± 3 mm (Applicant Device)
Size M: 95 ± 5 mm (ASTM D5250-92), 98 ± 3 mm (Applicant Device)
Size L: 105 ± 5 mm (ASTM D5250-92), 106 ± 3 mm (Applicant Device)
Size XL: 115 ± 5 mm (ASTM D5250-92), 114 ± 3 mm (Applicant Device)
Test: Thickness (mm)
Finger: Min. 0.05 mm (ASTM D5250-92), Min. 0.08 mm (Applicant Device)
Palm: Min. 0.08 mm (ASTM D5250-92), Min. 0.11 mm (Applicant Device)
Test: Physical Properties Before Aging
Tensile Strength (MPa): Min. 9 MPa (ASTM D5250-92), Min. 10 MPa (Applicant Device)
Ultimate Elongation (%): Min. 300% (ASTM D5250-92), Min. 300% (Applicant Device)
Test: After Aging
Tensile Strength (MPa): Min. 9 MPa (ASTM D5250-92), Min. 9.5 MPa (Applicant Device)
Ultimate Elongation (%): Min. 300% (ASTM D5250-92), Min. 300% (Applicant Device)
Test: FDA Water Leak Test
Meets AQL 4.0 with an Inspection Level of S-4 (Applicant Device)

Clinical Performance Data
The results of Modified Draize Test suggest the applicant device did not induce clinically significant irritation nor show any evidence of induced allergic contact dermatitis in human subjects.

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.

Not Found

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

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]

MAY 2 3 1997

K971423

Page 1 of 2

510 (k) Summary

Date of summary prepared: March 19, 1997

Applicant: l.

Shanghai Foremost Plastic Industrial Co., Ltd. Yan Li River Bridge East Che Xing Highway, Che Dun Town Songjiang County, Shanghai 201611 People's Republic of China Tel: [phone] Fax: [phone]

• 2. Contact Person:
     Dr. Tiang S. Chang 1016 Seward Avenue Westfield, N. J. 07090 Fax: [phone] e-mail: [e-mail] Tel: [phone]
• 3. Name of Device:
     Vinyl Patient Examination Gloves, Powdered
• 4. Device Description:
     Classified by FDA's General and Plastic Surgery Device Panel as Class I, CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, powdered with an absorbable dusting starch powder, USP, Class III and conform to all requirements of ASTM Standard D5250-92 and FDA 1000 ml water leak test.

• ર્ડ Intended Use
  The applicant device is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

1

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]

510 (k) summary continue.

page 2 of 2.

Comparison to Predicate Device 6.

Non-Clinical Performance data

Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000 ml water leak test for pin-holes.

Test		ASTM D5250-92	Applicant Device
Length (mm)
Size	S	Min. 230 mm	240 ± 5 mm
	M	Min. 230 mm	240 ± 5 mm
	L	Min. 230 mm	240 ± 5 mm
	XL	Min. 230 mm	240 ± 5 mm
Width (mm)
Size	S	85 ± 5 mm	87 ± 3 mm
	M	95 ± 5 mm	98 ± 3 mm
	L	105 ± 5 mm	106 ± 3 mm
	XL	115 ± 5 mm	114 ± 3 mm
Thickness (mm)
	Finger	Min. 0.05 mm	Min. 0.08 mm
	Palm	Min. 0.08 mm	Min. 0.11 mm
Physical Properties
Before Aging
	Tensile Strength (MPa)	Min. 9 MPa	Min. 10 MPa
	Ultimate Elongation (%)	Min. 300%	Min. 300%
After Aging
	Tensile Strength (MPa)	Min. 9 MPa	Min. 9.5 MPa
	Ultimate Elongation (%)	Min. 300%	Min. 300%
FDA Water Leak Test			Meets AQL 4.0 with a
Inspection Level of S-4

Clinical Performance Data

The results of Modified Draize Test suggest the applicant device did not induce clinically significant irritation nor show any evidence of induced allergic contact dermatitis in human subjects.

7. Conclusions

The applicant devices conform fully to ASTM D5250-92 and applicable 21 CFR requirements, and meets FDA 1000 ml Water Leak Test.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved shapes that resemble human figures or abstract forms.

MAY 2 3 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai Foremost Plastic Industrial Co, Ltd. C/O Mr. Robert Mosenkis ......... President ………… CITECH 5200 Butler Pike Plymouth Meetling, Pennsyvania 19462-1298

Re: K971423 Vinyl Patient Examination Glove, Powdered Trade Name: Requlatory Class: I Product Code: LYZ Dated: April 16, 1997 Received: April 17, 1997

Dear Mr. Mosenkis:

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 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 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 (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. ਖੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

3

Page 2 - Mr. Mosenkis

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as . . described in your $10(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) Additionally, for questions on the promotion and 594-4692. advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Direc 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 1 b

I İ of Page

Labels	Values
Number (if known):	KG711423

evice Name: Patient Examination Glove, Powdered

dications 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)

Olin S. Lim

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(Division Sign-Off)
Division of Dagcul, Infection Control

Division of Danial, Infection Control. and General Hospital Devic 510(k) Number

ecription Use 21 CFR 801.109)

OR

Over-The-Counter Use X

(Optional Format 1-2-96)