(43 days)
Powdered 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.
powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
Here's a breakdown of the acceptance criteria and study information for K101664, based on the provided text:
Reported 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' | Meets |
| Physical Properties | ASTM standard D 5250-06' | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06' | Meets |
| Biocompatibility (Overall) | ISO10993-10 (implied by "Meets requirements per... ISO10993-10") | <10mg/dm² |
| Primary Skin Irritation | ISO10993-10 (implied) | Passes (Not a Primary Skin Irritation) |
| Dermal Sensitization | ISO10993-10 (implied) | Passes (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for testing each characteristic (e.g., number of gloves tested for pinholes or dimensions). It only states that the device "Meets" the specified standards.
The data provenance is not specified (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for a Class I device like examination gloves, where performance standards are well-established.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. For examination gloves, the "ground truth" is typically defined by adherence to published ASTM and FDA standards, which involve objective measurements and tests rather than expert interpretation of complex data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where there is subjective interpretation of data (e.g., medical imaging) which necessitates a consensus among experts. For objective measurements of glove properties, such a method is not relevant.
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 information is not applicable. This device is a physical product (examination gloves), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. As mentioned, this is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device is based on established objective standards and test methods. Specifically:
- ASTM D 5250-06': Standard specification for vinyl examination gloves for medical application, covering dimensions, physical properties, and powder amount.
- 21 CFR 800.20: FDA regulation for freedom from pinholes (water leak test).
- ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).
8. The Sample Size for the Training Set
This information is not applicable. "Training set" refers to data used to train an AI algorithm. This device is not an AI algorithm. The manufacturing process for gloves involves quality control checks, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As this is not an AI device, there is no "training set" in the AI context, and thus no ground truth to be established for it. The product's compliance is directly assessed against the outlined standards.
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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: ______________________________________________________________________________________________________________________________________________
JUL 27 2010
Premarket Notification {510(k)} Sumnary
1(2)(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 EXCELLENT PLASTIC CO., LTD |
|---|---|
| Submitter's address : | RM602, UNIT 2, #43 BUILDING, LONGQUAN GARDEN,SHANGZHUANG TOWN LUQUAN CITY, HEBEI, 050081, CHINA |
| Phone number : | (86)- 311-83985366 |
| Fax number : | (86)- 311-83986358 |
| Name of contact person: | Mr. Edward Liu |
| Date the summary was prepared: | June 4th, 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 GlovesOther clients private labeling |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | 1 |
| 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 5250-06.
Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd., K032907.
[(a)(4)] A description of the device
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Device Description : powdered 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: powdered 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 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' | Meets |
| Physical Properties | ASTM standard D 5250-06' | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06' | Meets |
| Biocompatability | <10mg/dm² | |
| Primary Skin Irritation in rabbits | Passes | |
| Not a Primary Skin Irritation | ||
| Dermal sensitization in the guinea pig | Passes | |
| Not 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, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.
[(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 .
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Image /page/2/Picture/0 description: The image shows the 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 logo is black and white and appears to be a scanned image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Chu Xiaoan Hebei Excellent Plastic Company, Limited Room 1606 Building 1, Jianxiang Yuan #209 Bei Si Huan Zhong Road Beijing China 100083
JUL 27 2010
Re: K101664
Trade/Device Name: Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored) Rogulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 4, 2010 Received: June 14, 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/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Swan Purvis
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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INDICATIONS FOR USE
Applicant: HEBEI EXCELLENT PLASTIC CO., LTD
JUL 27 2010
510(k) Number (if known): *
Device Name:__Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)
Indications For Use:
Powdered 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 X (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)
ົກເພາະແ ວ້າງການໄປ
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _ K10166
§ 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.