(121 days)
Powder Free 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.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
The provided document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This is a medical device, but it is not an AI/ML powered device, nor is it a device that requires image analysis or complex diagnostic algorithms. Therefore, many of the requested criteria such as "test set", "training set", "experts", "ground truth", "adjudication method", and "MRMC comparative effectiveness study" are not applicable to this type of regulatory submission. The submission is for a physical product, a glove, and its performance is assessed against physical and chemical standards.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | 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 Residual | ASTM standard D 5250-06 e1 and D6124-06 | Meets (<2mg/glove) |
| Biocompatibility | Primary Skin Irritation in rabbits AAMI / ANSI / ISO 10993-10 | Passes (Not a Primary Skin Irritation) |
| Dermal sensitization in the guinea pig AAMI / ANSI / ISO 10993-10 | Passes (Not a Dermal sensitization) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in a detailed manner that specifies exact sample sizes for each test. The document states that the device "meets 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." These standards inherently define testing methodologies and sample sizes (e.g., AQL levels for pinhole tests), but the specific results for the exact number of gloves tested are not enumerated in this summary. The manufacturer is based in China. The provenance of the data is the tests conducted by the manufacturer to meet these standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for this device (a glove) is established by adherence to physical, chemical, and biological performance standards, not by expert interpretation of images or other subjective data. Testing personnel performing the standard tests would be technicians qualified to conduct those specific tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a diagnostic device requiring adjudication of results from multiple readers. The results are determined by objective tests against established standards.
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
Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth is based on established industry standards and regulations for medical gloves, including:
- ASTM standard D 5250-06 e1 (for dimensions and physical properties)
- 21 CFR 800.20 (for freedom from pinholes)
- ASTM standard D6124-06 (for powder residual)
- AAMI / ANSI / ISO 10993-10:2002 (for biocompatibility - primary skin irritation and dermal sensitization)
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this type of device.
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Section C 510(k) Summary (21 CFR 807.92)
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: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AUG - 6 2010
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 Products Co.,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: | Powder Free Vinyl Patient Examination Gloves,Clear (non-colored) |
|---|---|
| Proprietary/Trade name: | Powder Free 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* Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
Section C
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Predicate device: FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
[(a)(4)] A description of the device
Device Description: Powder Free 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: Powder Free 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 Powder Free Vinyl Patient Examination Gloyes, 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 Residual | ASTM standard D 5250-06 eland D6124-06 | Meets<2mg/glove |
| 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 .
Powder Free 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 Powder Free 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 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is as safe, as effective, and performs as well as the predicate device, FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol resembling an abstract human form or a caduceus, with three wavy lines extending upwards.
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 Beijing Easy-Link Company, Limited 209 Bei Si Huan Zhong Road Hai Di Room 1606 Building 1 Beijing China 100083
Re: K100963
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (noncolored)
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
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.
AUG - 6 2010
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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 yours.
Susan Tunner
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): *
Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications For Use:
Powder Free 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)
Elizabeth B. Vanwie-Will
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K 100963
§ 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.