(100 days)
Powdered Vinyl Patient Examination Gloves, 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.
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Powdered Vinyl Patient Examination Gloves, Clear (non-colored)
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06 e1 and D6124-06 | <10mg/dm² |
| Biocompatibility: | AAMI / ANSI / ISO 10993-10 | |
| - Primary Skin Irritation | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| - Dermal Sensitization | Dermal sensitization in the guinea pig | Passes (Not a Dermal sensitization) |
2. Sample Size and Data Provenance for Test Set
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 animals for biocompatibility).
The data provenance is for a device manufactured by "Hebei Shenzichen Plastic& Rubber Products Co.,Ltd." in "Ciyutuo Development Area,Luan County,Tangshan City,Hebei Province,063100,China". All data appears to be retrospective as it's presented as results of tests already conducted to demonstrate compliance with established standards.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This information is not provided in the document. The tests described are laboratory-based and standard-driven (e.g., ASTM, CFR, ISO). While technicians with specific qualifications would have performed these tests, the concept of "experts establishing ground truth" in the diagnostic or clinical sense, with defined numbers and qualifications (e.g., radiologists), does not apply directly to the evaluation of a medical device like examination gloves against mechanical and biological standards.
4. Adjudication Method for Test Set
Not applicable in the context presented. The tests performed are objective, standards-based evaluations (e.g., measuring dimensions, physical properties, pinhole presence, powder amount, and biological responses in animals). There is no indication of human interpretation or disagreement requiring an adjudication process for these types of tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or interpretive AI systems where human readers interpret medical images or data. The device in question is a physical medical glove and does not involve human interpretation of output.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a passive medical device (an examination glove) and does not involve an algorithm or AI. Therefore, there is no "standalone" algorithm performance to evaluate.
7. Type of Ground Truth Used (Test Set)
The ground truth used for the test set is based on:
- Established Industry Standards: ASTM standard D 5250-06 e1 and D6124-06 for physical properties, dimensions, and powder amount.
- Regulatory Standards: 21 CFR 800.20 for freedom from pinholes.
- International Biological Evaluation Standards: AAMI / ANSI / ISO 10993-10 for biocompatibility (primary skin irritation and dermal sensitization).
These standards define the objective pass/fail criteria.
8. Sample Size for the Training Set
Not applicable. The device is a physical product (a glove), not an AI algorithm. Therefore, there is no "training set" in the machine learning sense. The manufacturing process is likely subject to quality control and statistical process control, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as #8. There is no training set for this type of device.
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Section C 510(k) Summary (21 CFR 807.92)
JUL 1 G 2010
510(k) 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: ______________________ " (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 : | Hebei Shenzichen Plastic& Rubber ProductsCo.,Ltd. |
|---|---|
| Submitter's address : | Ciyutuo Development Area,Luan County,TangshanCity,Hebei Province,063100,China |
| Phone number : | 86-315-5028919 |
| Fax number : | 86-315-5028919 |
| Name of contact person: | Mr.Xu Gang |
| Date the summary was prepared: | Mar.19, 2010 |
[(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: | Powdered Vinyl Patient Examination Gloves,Clear (non-colored) |
|---|---|
| Proprietary/Trade name: | Powdered Vinyl Patient Examination Gloves,Clear (non-colored)Other clients private labeling |
| Common Name: | Exam gloves |
| 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* Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
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Gloves. Predicate device: Powdered Vinyl Patient Examination Clear(Non-colored) , ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. K091662.
[(a)(4)] A description of the device
Device Description: Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powdered Vinyl Patient Examination Gloves, 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 Powdered Vinyl Patient Examination Gloves, Clear (non-colored), 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 el. | Meets |
| Physical Properties | ASTM standard D 5250-06 el. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06 eland D6124-06 | <10mg/dm² |
| Biocompatability | Primary Skin Irritation in rabbitsAAMI / ANSI / ISO 10993-10 | PassesNot a Primary Skin Irritation |
| Dermal sensitization in the guinea pigAAMI / ANSI / ISO 10993-10 | PassesNot 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 .
Powdered Vinyl Patient Examination Gloves, Clear (non-colored), meet requirements per ASTM D5250-06 e1, 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 Powdered Vinyl Patient Examination Gloves. Clear (non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .
It can be concluded that the Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is as safe, as effective, and performs as well as the predicate device, Powdered Vinyl Patient Examination Gloves, Clear(Non-colored) ,ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. K091662.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hebei Shenzichen Plastic & Rubber Products Company, Limited C/O Mr. Chu Xiaoan 209 Bei Si Huan Zhong Road Hai D Room 1606 Building 1 Beijing, China 100083
Re: K100964
Trade/Device Name: Powdered Vinyl patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: March 20, 2010 Received: May 13, 2010
JUL 1 6 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Section B Indications for Use
INDICATIONS FOR USE
Applicant: Hebei Shenzichen Plastic& Rubber Products Co.,Ltd.
510(k) Number (if known): *
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) Device Name:
Indications For Use:
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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)
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K100964 510(k) Number: ___
§ 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.