(76 days)
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.
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.
This document describes the acceptance criteria and the study conducted for "POWDER-FREE VINYL EXAMINATION GLOVES, CLEAR (NON-COLORED)" by Quantum Co., Ltd.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D5250-06 "Standard Specification for Polyvinyl Examination Gloves for Medical Application" (includes physical properties like tensile strength, elongation, barrier integrity [e.g., freedom from holes]) | Gloves meet all the current Specifications listed under the ASTM D5250-06 Standard Specification for Vinyl Examination Gloves. |
| 21 CFR 800.20 (Quality System Regulation for medical devices, which implicitly covers aspects like manufacturing controls) | Gloves meet all the current Specifications listed under the ASTM D5250-06 Standard Specification for Vinyl Examination Gloves. |
| Primary Skin Irritation testing (in rabbits) | No irritation. |
| Delayed Contact Sensitization testing (in guinea pigs) | No sensitization. |
| Biocompatibility requirements (general term, but specifically covered by the irritation and sensitization tests) | Biocompatibility requirements are met (as indicated by the animal studies). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for the "test set" for each individual performance criterion. However, it indicates that testing was performed "as per ASTM D5250-06". This ASTM standard outlines specific sampling plans for various tests (e.g., water leak test for pinholes, physical dimensions, physical properties). Without access to the full test report or the specific ASTM D5250-06 standard, the precise sample size cannot be determined from the provided text.
The data provenance is not explicitly stated in terms of country of origin but is implied to be from the manufacturer (Quantum Co., Ltd.) based in China. The study is retrospective in the sense that the testing was conducted on samples of the manufactured product to demonstrate compliance with existing standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this device and study. The "ground truth" for the performance of examination gloves is established by objective, standardized laboratory tests (e.g., tensile strength machines, water leak testers, animal studies for biocompatibility), not by expert consensus or interpretations.
4. Adjudication method for the test set
This section is not applicable to this device and study. Adjudication methods (like 2+1, 3+1) are typically used in studies where subjective assessments by multiple human readers are involved (e.g., image interpretation). The performance of examination gloves is evaluated through objective physical and chemical tests.
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 section is not applicable to this device and study. This device is a medical glove, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable to this device and study. This device is a physical product (medical glove), not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on:
- Objective, standardized physical and chemical measurements: These include tests for tensile strength, elongation, dimensions, freedom from holes (barrier integrity), and weight. These are defined within the ASTM D5250-06 standard.
- Biocompatibility testing: Animal models (rabbits for primary skin irritation and guinea pigs for delayed contact sensitization) were used to establish the "ground truth" regarding the absence of adverse biological reactions.
8. The sample size for the training set
This section is not applicable to this device and study. The concept of a "training set" is relevant for machine learning or AI models, which are not involved in the evaluation of this medical glove.
9. How the ground truth for the training set was established
This section is not applicable to this device and study, as there is no "training set" in the context of this product's evaluation.
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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 Examinationglove, clear (Non-colored) is disposabledevice made PVC resin and plasticizers(DINP), Ca-Zn stabilizer, TXIB into film,coated with Polyurethane to facilitatedonning and it intended to be worn onthe hand of finger(s) for medical purposeto provide a barrier against potentiallyinfectious materials and othercontaminants. |
| Legally Marketed Device To WhichEquivalency is Being Claimed | Powder-free vinyl Examination glove,clear (Non-colored) is described in the510 (k) notification are substantiallyequivalent to the Class I patientexamination gloves, Vinyl, 80LYZ coatedwith Polyurethane dusting powder, thatmeets the current ASTM D5250-06"Standard Specification for PolyvinylExamination Gloves for MedicalApplication" |
| Predicate Device | A) K070149 POWDER-FREE VINYLPATIENT EXAMINATION GLOVESMANUFACTURED BY: WUXISHENZHOU PLASTIC PRODUCTSCO., LTD. |
| Predicate Device | B) K073193 POWDER-FREE VINYLPATIENT EXAMINATION GLOVES |
| MANUFACTURED BY: SHIJIAZHUANGPROSPEROUS PLASTIC CO., LTD. | |
| Summary of TechnologicalCharacteristicsComparedtothePredicate DevicePerformance testing report | Technological characteristics. Gloves aremade from PVC and DINP compoundand the initial products are powder freevinylexaminationgloves,clear(non-colored). |
| Intended use of the Device | A Powder-free vinyl Examination glove,clear (Non-colored) is a disposabledevice intended for medical purposesthat is worn on the examiner's hand orfinger to prevent contamination betweenpatient and examiner. |
| Brief Discussion of Nonclinical Tests | Testing is performed as per ASTMD5250-06 and 21 CFR 800.20, glovesmeet all the current Specifications listedunder the ASTM D5250-06 StandardSpecification for VinylExaminationGloves.Primary Skin Irritation testing in therabbit and delayed contact Sensitizationtesting in the guinea pig indicate noirritation or sensitization. |
| Brief Discussion of Clinical Tests | No new clinical tests were conductedunder this 510 (k) |
| Conclusions Drawn for the Non clinicaland Clinical Tests | Non-clinical Laboratory and animal dataindicate that the pre-powderedvinylproducts meet all performanceandbiocompatibility requirements. |
| Other Information Deemed Necessary byFDA | Non Applicable |
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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.
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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
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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
§ 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.