← Product Code [LYZ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ) · K083600 # VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED) (K083600) _Quantum Co., Ltd. · LYZ · Feb 19, 2009 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K083600 ## Device Facts - **Applicant:** Quantum Co., Ltd. - **Product Code:** [LYZ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ.md) - **Decision Date:** Feb 19, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use A Powder-free vinyl Examination glove, clear (non-colored) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. ## Device Story Disposable powder-free vinyl examination glove; manufactured from PVC resin, DINP plasticizers, Ca-Zn stabilizer, and TXIB; coated with polyurethane to facilitate donning. Used in clinical settings by healthcare providers as a protective barrier against infectious materials and contaminants. Device provides physical separation between examiner and patient to reduce cross-contamination risk. ## Clinical Evidence No clinical data. Bench testing performed per ASTM D5250-06 and 21 CFR 800.20. Biocompatibility testing included primary skin irritation (rabbit) and delayed contact sensitization (guinea pig), showing no irritation or sensitization. ## Technological Characteristics Material: PVC resin, DINP plasticizers, Ca-Zn stabilizer, TXIB. Coating: Polyurethane. Form factor: Disposable, powder-free, clear (non-colored) vinyl glove. Standards: Meets ASTM D5250-06. ## 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 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ([K070149](/device/K070149.md)) - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ([K073193](/device/K073193.md)) ## 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}------------------------------------------------ K083600 ## Executive Summary of FEB 1 9 2009 # POWDER-FREE VINYL EXAMINATION GLOVES, CLEAR (NON-COLORED) | Submitter's Name | Quantum Co., Ltd | |------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's address | No. 2-3-18 Hua Sheng Yuan Park, Linzi,
Shandong 255410 China | | Submistter's Telphone Number | +86-533-7480087 | | Submiter's Fax Number | +86-533-7480085 | | Name of Contact Person | Lijuan Wang | | Date of Preparation | November 20th, 2008 | | Device Description | The Powder-free vinyl Examination
glove, clear (Non-colored) is disposable
device made PVC resin and plasticizers
(DINP), Ca-Zn stabilizer, TXIB into film,
coated with Polyurethane to facilitate
donning and it intended to be worn on
the hand of finger(s) for medical purpose
to provide a barrier against potentially
infectious materials and other
contaminants. | | Legally Marketed Device To Which
Equivalency is Being Claimed | Powder-free vinyl Examination glove,
clear (Non-colored) is described in the
510 (k) notification are substantially
equivalent to the Class I patient
examination gloves, Vinyl, 80LYZ coated
with Polyurethane dusting powder, that
meets the current ASTM D5250-06
"Standard Specification for Polyvinyl
Examination Gloves for Medical
Application" | | Predicate Device | A) K070149 POWDER-FREE VINYL
PATIENT EXAMINATION GLOVES
MANUFACTURED BY: WUXI
SHENZHOU PLASTIC PRODUCTS
CO., LTD. | | Predicate Device | B) K073193 POWDER-FREE VINYL
PATIENT EXAMINATION GLOVES | | | MANUFACTURED BY: SHIJIAZHUANG
PROSPEROUS PLASTIC CO., LTD. | | Summary of Technological
Characteristics
Compared
to
the
Predicate Device
Performance testing report | Technological characteristics. Gloves are
made from PVC and DINP compound
and the initial products are powder free
vinyl
examination
gloves,
clear
(non-colored). | | Intended use of the Device | A Powder-free vinyl Examination glove,
clear (Non-colored) 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. | | Brief Discussion of Nonclinical Tests | Testing is performed as per ASTM
D5250-06 and 21 CFR 800.20, gloves
meet all the current Specifications listed
under the ASTM D5250-06 Standard
Specification for Vinyl
Examination
Gloves.
Primary Skin Irritation testing in the
rabbit and delayed contact Sensitization
testing in the guinea pig indicate no
irritation or sensitization. | | Brief Discussion of Clinical Tests | No new clinical tests were conducted
under this 510 (k) | | Conclusions Drawn for the Non clinical
and Clinical Tests | Non-clinical Laboratory and animal data
indicate that the pre-powdered
vinyl
products meet all performance
and
biocompatibility requirements. | | Other Information Deemed Necessary by
FDA | Non Applicable | : 100 ~: : . {1}------------------------------------------------ 100 - 100 - .. . . . . . : . {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### FEB 1 9 2009 Ms. Lijuan Wang Operation Manager Quantum Company, Limited Number 2-3-18 Hua Sheng Yuan Park Linzi Shandong 255410 CHINA K083600 Re: > Trade/Device Name: Powder-Free Vinyl Examination Gloves, Clear (Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 1, 2009 Received: February 4, 2009 Dear Ms. Wang: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general 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 against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ ### Page 2 - Ms. Wang Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Mishranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sinceraly yours, Anthony D. Watson for Ginette Y. Michaud, M.D. Acting Director. Division of Anesthesiology, General Hospital, Infection Control and-Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ QUANTUM CO.,LTD. No. 2-3-18 Hua Sheng Yuan Park, Linzi, Shandong 255410 China Tel: +86-533-7480087 Fax: +86-533-7480085 Attachment # Indications for Use 510(k) Number (if known): _K083600 Device Name: _Powder-Free, Vinyl Examination Gloves, Clear (Non-Colored) Indications for Use: Powder-free vinyl Examination glove, clear (non-colored) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between t patient and examiner. 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 Yours faithfully signature Ms. Lijuan Wang Operation Manager Date: Jan 29, 2009 Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart ) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shuli A. Murphy, MD (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K083606 Page of --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K083600](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K083600) **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