QTEXX Pre - Powdered 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

QTEXX Pre - Powdered Nitrile Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 99 Standard Specification for Rubber Examination Gloves. They are blue or natural white in colour.

AI/ML Overview

Here's an analysis of the provided text regarding the QTEXX Pre-Powdered Nitrile Examination Gloves, broken down into the requested categories. Please note that the document is a 510(k) summary for a medical glove, which is a low-risk device. As such, the types of studies and information typically found for higher-risk diagnostic or AI-driven devices are not present.

1. A table of acceptance criteria and the reported device performance

For medical gloves, "acceptance criteria" are typically the standards and specifications they must meet. In this case, the primary standard is ASTM D 3578-99.

Acceptance Criteria (Standard)	Reported Device Performance
ASTM D 3578-99 Standard Specification for Rubber Examination Gloves for Medical Applications	QTEXX Pre-Powdered Nitrile Examination Gloves meet all the current specifications listed under ASTM D 3578-99.
21 CFR 800.20 (Puncture Resistance, etc.)	QTEXX Pre-Powdered Nitrile Examination Gloves meet all the current specifications listed under 21 CFR 800.20 (implied, as this is for medical glove performance).
Primary Skin Irritation	No irritation indicated in rabbit testing.
Delayed Contact Sensitization	No sensitization indicated in guinea pig testing.
Presence of Starch (USP iodine test)	Negative for the test for presence of starch.
Biocompatibility requirements	Product meets all biocompatibility requirements (implied through irritation/sensitization testing).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: This information is not explicitly provided in the summary. For non-clinical tests like those specified in ASTM D 3578-99, specific sampling plans are typically outlined within the standard itself.
Data Provenance: The tests were performed by the manufacturer, LATEXX PARTNERS BERHAD, located in Kamunting, Perak, Malaysia. The testing is non-clinical/laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable for a medical glove submission. "Ground truth" in the context of medical gloves refers to objective physical and chemical testing against established standards (ASTM, FDA regulations) as well as animal model biocompatibility tests, not expert interpretation of diagnostic data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for a medical glove submission. Adjudication methods are typically used in clinical studies or for subjective assessments (e.g., image interpretation), not for standardized physical property testing of manufactured goods.

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

This is not applicable for a medical glove submission. MRMC studies are used for diagnostic devices, particularly those involving human interpretation of data, often in conjunction with AI. This is a low-risk medical device (examination glove) where AI assistance or human reader performance improvement is not relevant.

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

This is not applicable. This device is a physical medical product, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for medical gloves is established by:

Established Industry Standards: Primarily ASTM D 3578-99, which defines the physical and performance requirements (e.g., tensile strength, elongation, barrier properties, freedom from holes).
Regulatory Requirements: 21 CFR 800.20, which deals with specific performance characteristics like freedom from holes.
Biocompatibility Testing: Animal models (rabbit for primary skin irritation, guinea pig for delayed contact sensitization) provide objective data on biological response.
Chemical Testing: USP iodine test for starch presence.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a manufactured medical glove. The product's design and manufacturing process are developed to meet the specified standards, not "trained" on data.

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

This is not applicable. As there is no training set, there is no ground truth for it.

Summary

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SEP 2 4 1999 510(k) SUMMARY

QTEXX PRE – POWDERED NITRILE EXAMINATION GLOVES

Submitter's Name :	LATEXX PARTNERS BERHAD
Submitter's Address :	PT 5054, Kamunting Industrial Estate,P.O. Box 934600 Kamunting, PerakMalaysia
Submitter's Phone Number	605 891 5555
Submitter 's Fax Number :	605 891 2688
Name of Contact Person :	Lim, Chong Eng
Date of Preparation :	September 9, 1999
Name of Device :Trade Name :Common NameClassification Name :Legally Marketed Device to WhichEquivalency is Being Claimed :	QTEXX PRE - POWDERED NITRILEEXAMINATION GLOVESNitrile examination glovesPatient Examination GlovesQTEXX Pre - Powdered Nitrile ExaminationGloves as described in the 510(k) notification aresubstantially equivalent to the Class 1 patientexamination glove (Nitrile) 80LZA, thatmeetsthe current ASTM D 3578 - 99 StandardSpecification for Rubber Examination Gloves forMedical Application.
Description of the Device :	QTEXX Pre - Powdered Nitrile ExaminationGloves meet the current specifications listedunder the ASTM Specification D 3578 - 99Standard Specification for Rubber ExaminationGloves. They are blue or natural white in colour.
Intended Use of the Device:	QTEXX Pre - Powdered Nitrile ExaminationGloves are intended for single use for medicalpurposes and are 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 are no different technologicalcharacteristics. Gloves are made from nitrilerubber compound and the initial products arepowdered nitrile examination gloves.
Brief Discussion of Nonclinical Tests :	Testing is performed as per ASTM D 3578 -99and 21 CFR 800.20. Gloves meet all the currentspecifications listed under the ASTMSpecification D 3578 - 99 Standard Specificationfor Nitrile Examination Gloves.Primary skin irritation testing in the rabbit anddelayed contact sensitization testing in the guineapig indicate no irritation or sensitization.Final product is negative for the test for presenceof starch 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 pre powdered nitrile product meets allperformance and biocompatability requirements.
Other Information Deemed Necessary byFDA :	Not applicable

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K940671

Attachment 14

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1999

Mr. C.E. Lim General Manger Latexx Partners Bhd. Latexx Farences on Industrial Estate P.O. Box 9, 34600 Kamunting, Taiping, Perak, Malaysia

K992671 Re : Qtexx Pre-Powdered Nitrile Examination Trade Name: Gloves (Blue) Regulatory Class: I Product Code: LZA September 9, 1999 Dated: September 14, 1999 Received:

Dear Mr. Lim:

We have reviewed your Section 510 (k) notification of intent to We have reviewed your section because and we have determined the market the device reference above (for the indications for device is substantially equivalie (iss marketed in interstate use stated in the encrobare, or a che enactment date of the commerce prior to May 20, 1979, or to devices that have been Medical Device Amendments, or as be provisions of the Federal reclassified in accordance trin one four and controle provi Food, Drug, and Cosmetic acc (no, reneval controls provisions
market the device, subject to the provisions of the Act The general controls provisions of the Act of the Act. of the Act. The general conual registration, listing of Include requirements turing practice, labeling, and devices, good manazactashis proposading and adulteration.

If your device is classified (see above) into either class II If your device is crabbirsa (solential Approval), it may (Special Controls) of Crabbil controls. Existing major be subject co such additionary device can be found in the Code of regulations arreceing itile 21, Parts 800 to 895. A rederal Regulations, freis Eir ination assumes compliance with Subscancially Cquiring Practice for Medical Devices: General the Good Manufacturing Fracerce 2) and that, through periodic (GMP) regulation (2) Crk Fart our Administration (FDA) will GMP Inspections, che rs. Failure to comply with the GMP verly such assumpcions. Farlatory action. In addition, FDA regulation may rebure in concerning your device in may publish rarener announce: this response to your the rederal hegional.
premarket notification submission does not affect any premarket notification babazares.
obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Lim

the Act for devices under the Electronic Product Radiation the Act for devices ander Federal laws or regulations.

This letter will allow you to begin marketing your device as Info recei will arem for your market notification. The FDA described in your siawn provivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate device robatsine 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 regulacion (ir devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on compriation and advertising of your device, please contact che Dromotion and Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Dinector 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 2

INDICATIONS FOR USE

Applicant	LATEXX PARTNERS BERHAD,PT 5054, Kamunting Industrial EstateP.O. Box 934600 Kamunting, PerakMalaysia
510(k) Number(if known)

QTEXX PRE – POWDERED Device Name . NITRILE EXAMINATION GLOVES (BLUE)

Indications For Use . •

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Qlin S. Lin

(Division Sign. Off Division of Der olvision
and Gener: and Gener 510(k) Nurcher

Over-The-Counter OR

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.