Proflex Powderfree Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

Device Description

PROFLEX* Powder Free Nitrile Examination Gloves meet the current draft ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 3578 – 95, Standard Specification for Rubber Examination Gloves, EXCEPT for tensile strength and ultimate elongation requirement. They are blue or natural white in colour and are powder free.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the PROFLEX* POWDER FREE NITRILE EXAMINATION GLOVES, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (examination gloves). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing against established standards. It does not typically involve clinical studies with human participants in the way that, for example, an AI diagnostic device would. Therefore, many of the requested fields related to human readers, experts, ground truth for AI, etc., are not applicable to this type of device and submission.

1. Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are based on compliance with established industry standards for examination gloves.

Acceptance Criteria (Standard)	Reported Device Performance
ASTM D 3578-95 (Standard Specification for Rubber Examination Gloves) - All specifications	Meets all specifications EXCEPT for tensile strength and ultimate elongation.
Current Draft ASTM Standard Specification for Nitrile Examination Gloves for Medical Application - All specifications	Meets all specifications.
21 CFR 800.20	Complies with the regulatory requirement.
Primary skin irritation testing in the rabbit	Indicates no irritation.
Delayed contact sensitization testing in the guinea pig	Indicates no sensitization.
USP iodine test for starch	Negative for the presence of starch.
Biocompatibility requirements	Meets all requirements.
Performance requirements	Meets all requirements.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided text. Testing was performed "per ASTM D 3578-95 (also per current draft ASTM Standard Specification for Nitrile Examination Gloves for Medical Application) and 21 CFR 800.20." These standards typically define sampling plans for testing.
Data Provenance: Not specified. The testing was conducted by the manufacturer, Latex Partners Bhd. (Malaysia). The tests are non-clinical (laboratory and animal studies).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This is a non-clinical device performance study. Ground truth is established by objective measurements against specified standard criteria (e.g., physical properties, chemical tests).

4. Adjudication Method for the Test Set

Not Applicable. This is a non-clinical device performance study. Test results are compared directly to the specified criteria in the standards.

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

No. This type of study is entirely irrelevant for an examination glove. This is a non-clinical device.

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

No. This is a non-clinical device, not an AI algorithm.

7. The Type of Ground Truth Used

Standard Specifications and Objective Measurements: For the physical properties (e.g., dimensions, freedom from holes), chemical properties (e.g., starch presence), and biological safety (skin irritation, sensitization), the "ground truth" is established by the specified requirements in the ASTM standards and the results of laboratory tests (e.g., animal studies for biocompatibility).

8. The Sample Size for the Training Set

Not Applicable. This is a non-clinical device, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not Applicable. This is a non-clinical device, not an AI algorithm.

Summary

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K981159

1 1998 JUN

510(k) SUMMARY

PROFLEX* POWDER FREE NITRILE EXAMINATION GLOVES

Submitter's Name :	Latex Partners Bhd.
Submitter's Address :	PT 5054, Kamunting Industrial Estate
	34600 Taiping Perak
	Malaysia
Submitter's Phone Number	605 891 5555
Submitter 's Fax Number :	605 891 2688
Name of Contact Person :	Goh, See Khek
Date of Preparation :	February 25, 1998
Name of Device :
Trade Name :	PROFLEX* POWDER FREE NITRILEEXAMINATION GLOVES
Common Name :	Nitrile examination gloves
Classification Name :	Patient Examination Gloves
Legally Marketed Device to WhichEquivalency is Being Claimed :	PROFLEX* Powder Free Nitrile ExaminationGloves as described in the 510(k) notification aresubstantially equivalent to the Class 1 patientexamination glove (Nitrile) 80LZA, that meetsthe current draft ASTM Standard Specificationfor Nitrile Examination Gloves for MedicalApplication. It also meets all the currentspecifications listed under the ASTMSpecification D 3578 - 95, Standard Specificationfor Rubber Examination Gloves, EXCEPT fortensile strength and ultimate elongation.
		Attachment 1
	Description of the Device :	PROFLEX* Powder Free Nitrile ExaminationGloves meet the current draft ASTM StandardSpecification for Nitrile Examination Gloves forMedical Application. It also meets all the currentspecifications listed under the ASTMSpecification D 3578 – 95, Standard Specificationfor Rubber Examination Gloves, EXCEPT fortensile strength and ultimate elongationrequirement. They are blue or natural white incolour and are powder free.
	Intended Use of the Device:	PROFLEX* Powder Free Nitrile ExaminationGloves are intended for single use for medicalpurposes that is worn on the hand of health careand similar personnel to prevent contaminationbetween the health care personnel and thepatients.
	Summary of TechnologicalCharacteristics Compared to the PredicateDevice :	There is no different technological characteristics.Gloves are made from Nitrile rubber compoundand the initial products are powdered Nitrilerubber gloves. These gloves are then furtherprocessed into powder free gloves using theexisting technology, i.e. washing and thenchlorinating the surfaces of the gloves.
	Brief Discussion of Nonclinical Tests :	Testing performed per ASTM D 3578-95 (alsoper current draft ASTM Standard Specificationfor Nitrile Examination Gloves for MedicalApplication) and 21 CFR 800.20. Gloves meetthe current draft ASTM Standard Specificationfor Nitrile Examination Gloves for MedicalApplication. Test results also show that theproduct meets all the current specifications listedunder the ASTM Specification D 3578 – 95,Standard Specification for Rubber Examination
K981159		Attachment 1
		Gloves, EXCEPT for tensile strength andultimate elongation requirements.Primary skin irritation testing in the rabbit anddelayed contact sensitization testing in the guineapig indicate no irritation of sensitization.Final product is negative for the presence ofstarch using the USP iodine test.
	Brief Discussion of Clinical Tests :	No new clinical tests were conducted under this510(k).
	Conclusions Drawn for the Nonclinicaland Clinical Tests :	Nonclinical laboratory and animal data indicatethat the powder free product meets allperformance and biocompatability requirements.
Other Information Deemed Necessary byFDA :		Not applicable

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1998 JUN

Mr. Goh See Knek · Latexx Partners Berhad PT 5054, Kamunting Industrial Estate 34600 Taiping Perak MALAYSIA

Re : K981159 Proflex* Powder Free Nitrile Examination Trade Name: Gloves Regulatory Class : I Product Code: LZA Dated: March 21, 1998 Received: March 31, 1998

Dear Mr. Goh See Knek:

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 legally marketed predicate 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 qeneral 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 aqainst 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS 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

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Page 2 - Mr. Goh See Khek

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 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

thy A. 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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INDICATIONS FOR USE

Applicant

LATEXX PARTNERS BHD. PT 5054, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA

K981159

510(k) Number (if known)

Device Name

PROFLEX POWDERFREE NITRILE EXAMINATION GLOVE

Indications For Use :

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Olim S. Lim

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

Prescription Use Per 21 CFR 801.109 OR Over-The-Counter

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.