BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE

• K Number: K992588
• Device Name: BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
• Manufacturer: FORMOSA GLOVE INDUSTRIAL CO., LTD.
• Date Cleared: 1999-09-10 ( 39 days)
• Product Code: LZA
• 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 Device Panel as Class I (21 CFR 880,6250), nitrile patient examination gloves, powder-free, 80 LZA. Meets all requirements of ASTM D5250, Standard for poly(vinyl chloride) gloves for medical application. Also meets all requirement of ASTM D3578, Standard for rubber examination gloves except for ultimate elongation before aging.

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 biocompatibility of examination gloves, with no mention of AI or ML.

Therapeutic

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

Diagnostic

No
The device is a patient examination glove, which is used to prevent contamination between patient and examiner. Its intended use does not involve diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical patient examination glove, not a software application. The description focuses on material properties and performance standards for a physical product.

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 "patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a physical barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or other conditions.
• Device Description: The device is classified as Class I under 21 CFR 880.6250, which is for patient examination gloves. IVDs are typically classified under different sections of the CFR related to in vitro diagnostic products.
• Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, or controls, which are characteristic of IVDs.
• Performance Studies: The performance studies focus on the physical properties of the glove (conformance to ASTM standards) and skin irritation/allergic reactions, not on the accuracy or reliability of diagnostic results.

In summary, the device is a physical barrier intended for infection control during patient examinations, not a diagnostic tool that analyzes biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
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)

LZA

Device Description

Classified by FDA's General and Plastic Device Panel as Class I (21 CFR 880,6250), nitrile patient examination gloves, powder-free, 80 LZA. Meets all requirements of ASTM D5250, Standard for poly(vinyl chloride) gloves for medical application. Also meets all requirement of ASTM D3578, Standard for rubber examination gloves except for ultimate elongation before aging.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

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 Date:
Applicant device conforms fully to ASTM D5250, Standard for poly(viny) chloride) gloves for medical application. It also meets all requirements of ASTM D3578, Standard for rubber examination gloves, except for ultimate elongation before aging. This device is substantially equivalent to those currently in commercial distribution.

Clinical Performance Date:
The results of repeated insult patch test (modified Draize test, human study) suggest the applicant device did not induce clinically significant irritation nor have any evidence of induced allergic contact dermatitis in the 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

FORMOSA GLOVE INDUSTRIAL C

NO. 10-8, MA-KUO-LI, MATOU TOWN, TAINAN HSIEN, TAIWAN, R.C. FAX: [phone] TEL: [phone]~6

SEP 1 0 1999

K992588

Page 1 of 2

510 (k) Summary

Date Prepared : July 30, 1999

• 1. Applicant
     Formosa Glove Industrial Co., Ltd. No 10-8, Ma-Kuo-Li, Matou Town, Tainan Hsien Taiwan Tel: [phone] Fax: [phone]
• 2. Contact Person
     Dr. Tiang S. Chang 1016 Seward Avenue Westfield, N. J. 07090 Tel: [phone] Fax: [phone]

E-mail: [e-mail]

• 3. Name of Device:

Classification Name	Patient Examination Glove
Common Name:	Blue Nitrile Examination Glove, Powder-free
	Synthetic Powder-free Examination Glove, Nitrile

• 4. Description:
     Classified by FDA's General and Plastic Device Panel as Class I (21 CFR 880,6250), nitrile patient examination gloves, powder-free, 80 LZA. Meets all requirements of ASTM D5250, Standard for poly(vinyl chloride) gloves for medical application. Also meets all requirement of ASTM D3578, Standard for rubber examination gloves except for ultimate elongation before aging.

• న్. Intended Use
  A disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

1

FORMOSA GLOVE INDUSTRIAL CO.,

NO. 10-8, MA-KUO-LI, MATOU TOWN, TAINAN HSIEN, TAIWAN, R. FAX: [phone] TEL: [phone]~6

510 (k) Summary continue ...

Page 2 of 2

Comparison to Predicate Device and Equivalence ર્ભ .

Non-clinical Performance Date:

Applicant device conforms fully to ASTM D5250, Standard for poly(viny) chloride) gloves for medical application. It also meets all requirements of ASTM D3578, Standard for rubber examination gloves, except for ultimate elongation before aging. This device is substantially equivalent to those currently in commercial distribution.

Clinical Performance Date:

The results of repeated insult patch test (modified Draize test, human study) suggest the applicant device did not induce clinically significant irritation nor have any evidence of induced allergic contact dermatitis in the human subjects.

7. Conclusions:

This device is safe, effective and substantially equivalent to those currently in commercial distribution. It conforms fully to ASTM D5250, Standard for poly(vinyl chloride) gloves for medical application and applicable 21 CFR requirements for label and marking. It also meets all requirements of ASTM D3578, Standard for rubber examination gloves, except for ultimate elongation before aging. The results of a repeated insult patch test suggest that the device does not induce clinically significant irritation nor show any evidence of induced allergic contact dermatitis in human subjects.

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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 features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1999

Formosa Glove Industrial Co., Ltd. Dr. Tiang S. Chang c/o: Official Correspondent 1016 Seward Avenue Westfield, New Jersey 07090

Re : K992588 Blue Nitrile Patient Examination Glove, Trade Name: Powder-free Requlatory Class: I Product Code: LZA Dated: July 30, 1999 Received: August 2, 1999

Dear Dr. Chang:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. Existinq major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in requlatory 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 obligation you might have under sections 531 through 542 of

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Page 2 - Dr. Chang

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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Other qeneral 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

Timo Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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FORMOSA GLOVE INDUSTRIAL CO., LT

NO. 10-8, MA-KUO-LI, MATOU TOWN, TAINAN HSIEN, TAIWAN, R. TEL: [phone]~6 FAX: [phone]

Indications for Use

Formosa Glove Industrial Co., Ltd. Applicant:

K992588 510(k) Number (if known):

Blue Nitrile Patient Examination Glove, Powder-free Device Name:

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)

Clim S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number

Prescription Use Per 21 CFR 801.109 ાર

Over the Counter Use X

(Optional Format 1-2-96)