(48 days)
Powder free vinyl 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.
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
The provided text describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)" manufactured by Zhang Jia Gang Fengyuan Plastic Products Co.,Ltd. This is a medical device submission, and the "study" described is the testing conducted to demonstrate substantial equivalence to a predicate device and adherence to relevant standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 (Water leak test on pinhole AQL) | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-06 | <2mg/glove |
| Biocompatibility (Primary Skin Irritation) | FDA recognition number 2-87: AAMI / ANSI / ISO 10993-10:2002 (Primary Skin Irritation in rabbits) | Pass (Not a Primary Skin Irritation) |
| Biocompatibility (Dermal Sensitization) | FDA recognition number 2-87: AAMI / ANSI / ISO 10993-10:2002 (Dermal sensitization in the guinea pig) | Pass (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many rabbits/guinea pigs were used for biocompatibility). The testing is described as meeting ASTM standards and CFR regulations, which inherently include statistically significant sample size requirements for their respective tests.
- Provenance: This is a submission from China (Zhang Jia Gang Fengyuan Plastic Products Co.,Ltd, Jiangsu, China). The data appears to be prospective in the sense that the manufacturer conducted these tests specifically to demonstrate compliance for their device before submitting for FDA clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a "ground truth" for the test set in the context of human annotation or interpretation. The tests are for physical and biological properties of the gloves, where the ground truth is established by objective measurements against predefined standards (ASTM, CFR, ISO). These tests are typically performed by laboratory technicians or qualified personnel following standard operating procedures, rather than expert clinicians establishing ground truth through consensus.
4. Adjudication Method for the Test Set
Not applicable. The tests are based on objective measurements and compliance with specified standards, not on human interpretation that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC) is generally relevant for imaging or diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. This submission is for patient examination gloves, which do not involve such interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an algorithmic or AI-based device, so the concept of standalone performance doesn't apply. The device itself (the glove) is being tested for its physical and biological properties.
7. Type of Ground Truth Used
The ground truth used is based on:
- Predefined Standards: ASTM standard D 5250-06, ASTM D6124-06.
- Regulatory Requirements: 21 CFR 800.20, 21 CFR 801, 21 CFR 803, 21 CFR 807, 21 CFR 820.
- International Standards: FDA recognition number 2-87: AAMI / ANSI / ISO 10993-10:2002.
These standards and regulations define the objective criteria and methodologies for determining dimensions, physical properties, freedom from pinholes, powder residue, and biocompatibility.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: K (9 We(3" (applicant leave blank)
Premarket Notification [510(k)] Summary
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | Zhang Jia Gang Fengyuan Plastic Products Co.,Ltd. | |
|---|---|---|
| Submitter's address : | Hengjing Village Tangqiao Town Zhang Jia GangJiangsu, China, 215615 | |
| Phone number : | (86) 512-68416802 | |
| Fax number : | (86) 512-68416685 | |
| Name of contact person: | Mr. Yu Bang Ting | |
| Date the summary was prepared: | May 26 2009 |
(a)(2)). The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear(non-colored) |
|---|---|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination GlovesOther 'clients private labeling |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* powder free vinyl patient examination gloves , Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
[(a)(4)] A description of the device
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Device Description : powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient 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.
[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06and D6124-06 | <2mg/glove |
| Biocompatability | Primary Skin Irritation inrabbits | PassNot a Primary Skin Irritation |
| Dermal sensitization in theguinea pig | PassNot a Dermal sensitization |
[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Powder free vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-87: AAMI / ANSI / ISO 10993-10:2002,
[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
[(b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).
It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zhang Jia Gang Fengyuan Plastic Products Company, Limited C/O Mr. Chu Xiaoan Chu Xiaoan Room 1606 Building 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District Beijing 100083 P. R. CHINA
Re: K091663
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)
JUL 2-7 2009
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove
Regulatory Class: I
Product Code: LYZ
Dated: May 30, 2009
Received: June 9, 2009
Dear Mr. Xiaoan:
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 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 - Mr. Xiaoan
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Sincerely yours,
Anthony D. an Anton for
S. B. S. M.
Susan Runner, D.D.S., M.A 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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INDICATIONS FOR USE
Applicant:_Zhang Jia Gang Fengyuan Plastic Products Co.,Ltd
1091663 .510(k) Number (if known):__
Device Name: _ Powder Free Vinyl Patient Examination Gloves, Clear(Non-colored)
Indications For Use:
Powder free vinyl 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please do not write below this line-continue on another Page if Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of CDER/CBER:
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091663
§ 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.