(106 days)
Powder Free Vinyl Patient Examination Gloves, White Color 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, White Color that meets all of the requirements of ASTM standard D 5250-06e1.
This document describes the acceptance criteria and performance for "Powder Free Vinyl Patient Examination Gloves, White Color".
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 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:
The document does not explicitly state the sample sizes used for each specific test (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility). However, it implies testing was conducted according to the referenced ASTM standards and 21 CFR regulations, which would stipulate appropriate sample sizes for these types of tests.
The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. Given the submitter's address is in China (Jiangsu Cureguard Gloves Co.,Ltd.), the testing was likely conducted in China. These would be prospective tests specifically performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the device is a medical glove, and "ground truth" in the context of expert consensus, pathology, or outcomes data is not relevant for its mechanical and biological safety testing. The "ground truth" is established by the specifications of the referenced ASTM standards and regulatory requirements (21 CFR).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable, as there is no subjective interpretation or need for expert adjudication in the objective physical and chemical tests performed on the gloves. The results are quantitative measurements against defined 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:
This is not applicable. This device is a passive medical glove, not an AI-powered diagnostic or assistive device. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This device is a medical glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on objective measurement standards and regulatory criteria. These include:
- ASTM standard D 5250-06 e1 (for dimension, physical properties, powder residual)
- 21 CFR 800.20 (for freedom from pinholes)
- ASTM D6124-06 (for powder residual)
- AAMI / ANSI / ISO 10993-10 (for biocompatibility - primary skin irritation and dermal sensitization)
8. The sample size for the training set:
This is not applicable. The device is a medical glove, not a machine learning model, so there is no concept of a "training set".
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for this type of device.
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MAR - 4 2010
Section C 510(k) Summary (21 CFR 807.92)
PDA CDRH DMC
JAN 27 2010
510(k) Summary
Received
"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 : | Jiangsu Cureguard Gloves Co.,Ltd. |
|---|---|
| Submitter's address : | No.205 Jianling Road, The Economic DevelopmentZone of Suqian City,JiangsuProvince,223800,China |
| Phone number : | 86-527-88286001 |
| Fax number : | |
| Name of contact person: | Ms.Lynn Lee |
Date the summary was prepared: Oct.30, 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, White Color |
|---|---|
| Proprietary/Trade name: | 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, White Color that meets all of the requirements of ASTM standard D 5250-06e1.
Section C(rev.02)
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Predicate device: Powder-Free Vinyl Patient Examination Gloves (Light Yellow), JIANGSU CUREGUARD GLOVE CO.,LTD. K081655
[(a)(4)] A description of the device
Device Description : Powder Free Vinyl Patient Examination Gloves, White Color 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, White Color 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, White Color, 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 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 e1andD6124-06 | Meets<2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbitsAAMI / ANSI / ISO ISO 10993-10Dermal sensitization in the guinea pigAAMI / ANSI / ISO ISO 10993-10 | PassesNot a Primary Skin IrritationPassesNot 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, White Color, 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 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, White Color meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 4 2010
Jiangsu Cureguard Glove Company, Limited C/O Mr. Chu Xiaoan Official Correspondent Beijing Easy-Link Company Room 1606 Building 1 Jianx Yuan, No. 209 Bei Si Huan Haidian District, Beijing China 100083
Re: K093576
Trade/Device Name:. Powder Free Vinyl Patient Examination Gloves, White Color Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: January 20, 2010 Received: January 27, 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/Safetv/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 yours,
Susan Sumner
Anthony D. Watson, B.S., M.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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QI
K093576
Section B Indications for Use
INDICATIONS FOR USE
Jiangsu Cureguard Gloves Co.,Ltd. Applicant:
510(k) Number (if known): *
Powder Free Vinyl Patient Examination Gloves, White Color Device Name:
Indications For Use:
Powder Free Vinyl Patient Examination Gloves, White Color 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)
Ealizath. F-Claurin Will
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093576
§ 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.