← Product Code [LZA](/productcode/LZA) · K992671 # QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES (K992671) _Latexx Partners Bhd. · LZA · Sep 24, 1999 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K992671 ## Device Facts - **Applicant:** Latexx Partners Bhd. - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Sep 24, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use QTEXX Pre - Powdered Nitrile Examination Gloves are intended for single use for medical purposes and are worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patients. ## Device Story QTEXX Pre-Powdered Nitrile Examination Gloves are single-use, blue or natural white nitrile rubber gloves. Designed for healthcare and similar personnel to serve as a protective barrier; worn on hands to prevent cross-contamination between user and patient. Device is non-sterile; manufactured from nitrile rubber compound. Used in clinical or similar settings. Healthcare providers don gloves manually; output is the physical barrier provided by the glove material. Benefits include reduction of contamination risk during medical examinations. ## Clinical Evidence No clinical tests were conducted. Evidence is based on non-clinical laboratory and animal testing, including ASTM D 3578-99 standard specification compliance, 21 CFR 800.20 testing, and biocompatibility studies (rabbit skin irritation, guinea pig sensitization). ## Technological Characteristics Nitrile rubber compound; blue or natural white color. Complies with ASTM D 3578-99 Standard Specification for Rubber Examination Gloves. Non-sterile. Single-use. No software or electronic components. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 1 ### 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 9
34600 Kamunting, Perak
Malaysia | | 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 Name
Classification Name :
Legally Marketed Device to Which
Equivalency is Being Claimed : | QTEXX PRE - POWDERED NITRILE
EXAMINATION GLOVES
Nitrile examination gloves
Patient Examination Gloves
QTEXX Pre - Powdered Nitrile Examination
Gloves as described in the 510(k) notification are
substantially equivalent to the Class 1 patient
examination glove (Nitrile) 80LZA, that
meets
the current ASTM D 3578 - 99 Standard
Specification for Rubber Examination Gloves for
Medical Application. | | Description of the Device : | 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. | | Intended Use of the Device: | QTEXX Pre - Powdered Nitrile Examination
Gloves are intended for single use for medical
purposes and are worn on the hand of health care
and similar personnel to prevent contamination
between the health care personnel and the
patients. | | Summary of Technological
Characteristics Compared to the Predicate
Device : | There are no different technological
characteristics. Gloves are made from nitrile
rubber compound and the initial products are
powdered nitrile examination gloves. | | Brief Discussion of Nonclinical Tests : | Testing is performed as per ASTM D 3578 -99
and 21 CFR 800.20. Gloves meet all the current
specifications listed under the ASTM
Specification D 3578 - 99 Standard Specification
for Nitrile Examination Gloves.
Primary skin irritation testing in the rabbit and
delayed contact sensitization testing in the guinea
pig indicate no irritation or sensitization.
Final product is negative for the test for presence
of starch using the USP iodine test. | | Brief Discussion of Clinical Tests : | No new clinical tests were conducted under this
510(k). | | Conclusions Drawn for the Nonclinical
and Clinical Tests : | Nonclinical laboratory and animal data indicate
that the pre powdered nitrile product meets all
performance and biocompatability requirements. | | Other Information Deemed Necessary by
FDA : | Not applicable | {1}------------------------------------------------ # K940671 #### Attachment 14 T . . {2}------------------------------------------------ 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 {3}------------------------------------------------ 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 {4}------------------------------------------------ Attachment 2 ## INDICATIONS FOR USE | Applicant | LATEXX PARTNERS BERHAD,
PT 5054, Kamunting Industrial Estate
P.O. Box 9
34600 Kamunting, Perak
Malaysia | |-----------------------------|---------------------------------------------------------------------------------------------------------------------| | 510(k) Number
(if known) | | QTEXX PRE – POWDERED Device Name . NITRILE EXAMINATION GLOVES (BLUE) Indications For Use . • 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. (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 X --- **Source:** [https://fda-staging.innolitics.com/device/K992671](https://fda-staging.innolitics.com/device/K992671) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com