← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K993912 # AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI (K993912) _Latexx Partners, Inc. · LYY · Feb 9, 2000 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K993912 ## Device Facts - **Applicant:** Latexx Partners, Inc. - **Product Code:** [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY.md) - **Decision Date:** Feb 9, 2000 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use AMBIDERM Powder Free Latex Examination Glove (coloured), with a protein labeling claim 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 Ambiderm Powder Free Latex Examination Gloves are single-use, colored (violet, blue, green, or pink) natural rubber latex gloves. Designed for use by healthcare personnel to serve as a protective barrier, preventing contamination between the clinician and the patient. The device is worn on the hands during medical examinations. It is manufactured to meet ASTM D 3578-99 standards and features a protein content labeling claim of 50 micrograms or less per gram. The gloves are powder-free, verified by USP Iodine testing. ## Clinical Evidence No clinical tests were conducted. Evidence is based on nonclinical laboratory and animal testing, including primary skin irritation (rabbit) and delayed contact sensitization (guinea pig) studies, which showed no irritation or sensitization. Starch presence was tested via USP Iodine test with negative results. ## Technological Characteristics Material: Natural rubber compound. Form factor: Powder-free examination gloves, colored (violet, blue, green, pink). Standards: ASTM D 3578-99. Biocompatibility: Tested per 21 CFR 800.20. Protein content: Claimed 50 micrograms or less per gram. ## 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}------------------------------------------------ # 510(K) SUMMARY # AMBIDERM POWDER FREE (COLORED) LATEX EXAMINATION GLOVES WITH PROTEIN CLAIMS OF 50 MICROGRAMS OR LESS PER GRAMS #### Submitter's Name: ## LATEXX PARTNERS INC. ## Submitter's Address: Name of Contact Person: Date of Preparation: October 20, 1999 Name of Device: Trade Name: Common Name: Classification Name: Legally Marketed Device to Which Equivalency is Being Claimed: lly Marketed Device to W ivalency is Being Claimed: Description of the Device: AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIMS OF 50 MICROGRAMS OR LESS PER GRAM Latex Examination Gloves Patient Examination Gloves Ambiderm Powder Free Latex Examination Gloves as described in the 510(k) notification are substantially equivalent to the class I patient examination glove 80LYY. It meets all the current spec listed under the ASTM specification D 3578-99 standard specification for rubber examination gloves. Ambiderm Powder Free Latex Examination Gloves with Protein Labeling Claim meet the current specifications listed under the ASTM specifications D 3578-99 standard specification for rubber examination gloves. They are Violet, Blue, Green or Pink colored. {1}------------------------------------------------ | Intended Use of the Device: | Ambiderm Powder Free Latex
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
patient. | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of Technological
Characteristics Compared to the Predicate
Device: | There are no different
technological characteristics.
Gloves are made from natural
rubber compound and the initial
products are powder free latex
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 specifications D 3578-99
standard specification for latex
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 test were
conducted under this 510(K) | | Conclusions Drawn for the Nonclinical
and Clinical Tests: | Nonclinical laboratory and animal
data indicate that the pre-
powdered natural product meets
all performance and
biocompatibility requirements. | | Other information Deemed Necessary by
FDA: | Not Applicable | : {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 9 2000 FEB Latexx Partners, Inc. c/o Mr. E.J. Smith Latexx Partners, Inc. Smith Associates P.O. Box 4341 21114 Crofton, MD Re : K993912 AMBIDERM Powder Free Latex Examination Trade Name: Gloves (Violet, Blue, Green and Pink), With Protein Content Labeling Claim (50 Micrograms Or Less) Regulatory Class: I Product Code: LYY November 1, 1999 Dated: Received: November 17, 1999 Dear Mr. Smith: 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, good 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. Existing major requlations 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 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 {3}------------------------------------------------ Page 2 - Mr. Smith 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 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 diaqnostic 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 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 Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): Device Name: AMBIDERM Powder Free Latex Examination Gloves (Coloured), with Protein Claims of 50 Micrograms or Less Per Gram. K993912 Classification Panel: 80LYY Indications for Use: AMBIDERM Powder Free Latex Examination Glove (coloured), with a protein labeling claim 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 NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) or Prescription Use Over-the-Counter Use Clim S. Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number _ --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K993912](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K993912) **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