← Product Code [LZA](/productcode/LZA) · K981159 # PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES (K981159) _Latexx Partners Bhd. · LZA · Jun 1, 1998 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K981159 ## Device Facts - **Applicant:** Latexx Partners Bhd. - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Jun 1, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use 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 Story Proflex Powder Free Nitrile Examination Gloves are single-use, blue or natural white nitrile rubber gloves. Manufactured by washing and chlorinating nitrile rubber to achieve a powder-free surface. Used by healthcare and similar personnel in clinical settings as a protective barrier to prevent cross-contamination between the wearer and the patient. The device is worn on the hands; it does not involve electronic inputs, algorithms, or software. Clinical benefit is derived from the physical barrier properties of the nitrile material, which has been tested for biocompatibility (primary skin irritation and delayed contact sensitization) and physical performance standards. ## Clinical Evidence No clinical tests were conducted. Evidence is based on non-clinical laboratory and animal testing, including biocompatibility (primary skin irritation in rabbits, delayed contact sensitization in guinea pigs) and physical performance testing per ASTM D 3578-95 and draft ASTM standards. Final product confirmed negative for starch via USP iodine test. ## Technological Characteristics Nitrile rubber compound; powder-free surface achieved via washing and chlorination. Dimensions and physical properties tested per ASTM D 3578-95 and draft ASTM Standard Specification for Nitrile Examination Gloves. Biocompatible; non-irritating and non-sensitizing. No electronic components, software, or energy sources. ## 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. ## Predicate Devices - Class 1 patient examination glove (Nitrile) 80LZA ## 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}------------------------------------------------ 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 NITRILE
EXAMINATION GLOVES | | | Common Name : | Nitrile examination gloves | | | Classification Name : | Patient Examination Gloves | | | Legally Marketed Device to Which
Equivalency is Being Claimed : | PROFLEX* Powder Free 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 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. | | | | | Attachment 1 | | | Description of the Device : | 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. | | | Intended Use of the Device: | PROFLEX* Powder Free Nitrile Examination
Gloves are intended for single use 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
patients. | | | Summary of Technological
Characteristics Compared to the Predicate
Device : | There is no different technological characteristics.
Gloves are made from Nitrile rubber compound
and the initial products are powdered Nitrile
rubber gloves. These gloves are then further
processed into powder free gloves using the
existing technology, i.e. washing and then
chlorinating the surfaces of the gloves. | | | Brief Discussion of Nonclinical Tests : | Testing 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. Gloves meet
the current draft ASTM Standard Specification
for Nitrile Examination Gloves for Medical
Application. Test results also show that the
product meets all the current specifications listed
under the ASTM Specification D 3578 – 95,
Standard Specification for Rubber Examination | | K981159 | | Attachment 1 | | | | Gloves, EXCEPT for tensile strength and
ultimate elongation requirements.

Primary skin irritation testing in the rabbit and
delayed contact sensitization testing in the guinea
pig indicate no irritation of sensitization.

Final product is negative for the 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 powder free product meets all
performance and biocompatability requirements. | | Other Information Deemed Necessary by
FDA : | | Not applicable | {1}------------------------------------------------ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {2}------------------------------------------------ . . . . . . ... ... ... ... : {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ ## 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 ж Indications For Use : 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. (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 X --- **Source:** [https://fda-staging.innolitics.com/device/K981159](https://fda-staging.innolitics.com/device/K981159) **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