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
• Type: Traditional
• Panel: General Hospital
• Age Range: All
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a "Blue Nitrile Examination Glove, Powder-free." This device is a patient examination glove, and the acceptance criteria and study described are related to its physical properties and hypoallergenic qualities, rather than a diagnostic AI device. Therefore, many of the requested categories (e.g., effect size of human readers with/without AI, sample size for training set, adjudication method for ground truth, expert qualifications) are not applicable to this type of medical device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Physical Properties:
Conformance to ASTM D5250 (Standard for poly(vinyl chloride) gloves for medical application)	Conforms fully to ASTM D5250.
Conformance to ASTM D3578 (Standard for rubber examination gloves)	Meets all requirements of ASTM D3578, except for ultimate elongation before aging.
Biocompatibility/Safety:
Did not induce clinically significant irritation (human study)	Results of repeated insult patch test (modified Draize test, human study) suggest the applicant device did not induce clinically significant irritation.
No evidence of induced allergic contact dermatitis (human study)	Results of repeated insult patch test (modified Draize test, human study) suggest the applicant device did not have any evidence of induced allergic contact dermatitis in the human subjects.

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

• Physical Properties: The document does not specify a separate "test set" for the physical properties. Compliance with ASTM standards typically involves testing a defined number of samples from manufacturing lots. The provenance is implied to be from the manufacturer (Formosa Glove Industrial Co., Ltd. in Taiwan). This would be a retrospective evaluation of manufactured samples.
• Biocompatibility (Repeated Insult Patch Test): The document states "human subjects" but does not specify the sample size for this study. The provenance is from a "human study," which would be prospective data collection. The location where this study was conducted is not mentioned.

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

• Not Applicable. For a patient examination glove, "ground truth" is established by adherence to recognized industrial standards (ASTM) for physical properties and by direct observation of human physiological responses in a clinical study for biocompatibility. There are no "experts" in the sense of radiologists or pathologists interpreting images for this device.

4. Adjudication method for the test set:

• Not Applicable. As there are no human interpretations of diagnostic images, no adjudication method would be used. The determination for physical properties is based on passing defined thresholds in ASTM tests. The biocompatibility study's results (e.g., absence of irritation) would be determined by clinical observation and possibly dermatological assessment, rather than an adjudication process.

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 patient examination glove, not an AI-powered diagnostic device. No MRMC study was performed.

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

• Not Applicable. This is a patient examination glove, not an AI algorithm.

7. The type of ground truth used:

• Physical Properties: The ground truth for physical properties is established by adherence to ASTM D5250 and ASTM D3578 standards, which define specific performance metrics and their corresponding acceptable ranges.
• Biocompatibility: The ground truth for biocompatibility is established by direct clinical observation of human subjects in a "repeated insult patch test (modified Draize test)," looking for absence of clinically significant irritation or allergic contact dermatitis. This is a form of outcomes data (clinical response).

8. The sample size for the training set:

• Not Applicable. This device is not an AI algorithm, so there is no training set in that context. The manufacturing process itself (where gloves are produced) could be seen as continuously "training" to meet specifications, but this isn't a "training set" in the machine learning sense.

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

• Not Applicable. There is no training set for an AI algorithm. For a manufactured product, the "ground truth" for manufacturing quality is established by the specifications and quality control procedures that ensure each batch meets the required standards (e.g., ASTM standards).

Summary

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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.

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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)

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.