(133 days)
Powder Free Nitrile 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 Nitrile Patient Examination Gloves, White Color are made of synthetic rubber, intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device meets all of the requirements of ASTM standard D 6319 00a (2005)e1.
The acceptance criteria and study proving the device meets these criteria are described below.
1. Acceptance Criteria and Device Performance
The device is "Powder Free Nitrile Patient Examination Gloves, White Color". The acceptance criteria and reported device performance are presented in the table below:
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 6319 00a (2005)e1. | Meets |
| Physical Properties | ASTM standard D 6319 00a (2005)e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 6319 00a (2005)e1. and D6124-06 | <2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10) | Passes (Not a Primary Skin Irritation) |
| Dermal sensitization in the guinea pig (ISO 10993-10) | Passes (Not a Dermal sensitization) |
2. Sample size used for the test set and data provenance
The document does not specify the exact sample sizes for the testing of the "Powder Free Nitrile Patient Examination Gloves, White Color." However, it states that the device meets various ASTM standards and CFR regulations, implying specific sample sizes as dictated by those standards.
The data provenance is not explicitly stated in terms of country of origin but is implied to be internal testing conducted by the manufacturer, Jiangsu Dongling Plastic & Rubber Co.,Ltd, located in China. The study appears to be retrospective in nature, as it involves testing the finalized product against established standards.
3. Number of experts used to establish the ground truth for the test set and their qualifications
This information is not provided in the document, as the testing involves meeting regulatory and industrial standards (e.g., ASTM, FDA 21 CFR) for product characteristics, rather than diagnostic accuracy requiring expert consensus.
4. Adjudication method for the test set
An adjudication method is not applicable and therefore not described in the document. The testing involves objective measurements against predefined standards for glove characteristics, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
An MRMC comparative effectiveness study was not done and is not applicable to this device. This type of study is typically used for diagnostic devices involving image interpretation or other subjective assessments. The "Powder Free Nitrile Patient Examination Gloves, White Color" is a medical device (patient examination glove) whose effectiveness is determined by its physical and chemical properties as per standards, not by human reader interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study is not applicable to this device. This type of study is typically associated with AI/algorithm-based diagnostic tools. The "Powder Free Nitrile Patient Examination Gloves, White Color" is a physical medical device.
7. Type of ground truth used
The ground truth used for evaluating the "Powder Free Nitrile Patient Examination Gloves, White Color" is based on established industry and regulatory standards:
- ASTM standard D 6319 00a (2005)e1: For dimensions and physical properties.
- 21 CFR 800.20: For freedom from pinholes (waterleak test on pinhole AQL).
- ASTM standard D6124-06: For powder residual.
- ISO 10993-10: 2002/Amd. 1: 2006: For biocompatibility (primary skin irritation and dermal sensitization).
These standards define the acceptable performance parameters.
8. Sample size for the training set
This information is not applicable and therefore not provided in the document. The "Powder Free Nitrile Patient Examination Gloves, White Color" is a physical medical device, not an AI/algorithm-based device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided in the document. As stated above, this device does not utilize a training set in the context of inferential algorithms.
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Section C (rev.02)510(k) Summary (21 CFR 807.92)
510(K) Summary
JUN 1 0 2011
"This summary of 510(k) safety and effectiveness information is being submitted in This Sunmary - or -510(x) - Sales - SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: K110248
Premarket Notification {510(k)] Summary
| Submitter's name : | JiangSu DongLing Plastic & Rubber Co.,Ltd |
|---|---|
| Submitter's address : | DongWu Road, Economic Development Zone,SuQian, JiangSu Province, 223800,China |
| Phone number : | 0086-527-82860080 |
| Fax number : | 0086-527-82860080 |
| Name of contact person: | Mr.ZhiJun Xu |
| Date the summary was prepared: | Dec.24, 2010 |
| Device Name: | Powder Free Nitrile Patient ExaminationGloves, White Color |
|---|---|
| Proprietary/Trade name: | Powder Free Nitrile Patient ExaminationGloves, White ColorOther 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: | LZA |
Class I* Powder Free Nitrile Patient Examination Gloves,White Color that meets all of the requirements of ASTM D 6319 00a(2005)e1.
Predicate device: POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. K082598.
Device Description: Powder Free Nitrile Patient Examination Gloves,White Color are Device Description: Tree Tree Tritrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and 15 worn on the exammer 3 mand of the requirements of ASTM standard D 6319 00a (2005)el .
Section C
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Device Intended Use (indication for use): Powder Free Nitrile 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 summary of the technological characteristics of new device compared to the predicate device.
The Powder Free Nitrile 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 6319 00a (2005)e1. | Meets |
| Physical Properties | ASTM standard D 6319 00a (2005)e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 6319 00a (2005)e1.and D6124-06 | <2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbitsISO 10993-10 | PassesNot a Primary Skin Irritation |
| Dermal sensitization in the guinea pigISO 10993-10 | PassesNot a Dermal sensitization |
A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Powder Free Nitrile Patient Examination Gloves, White Color, meet requirements per ASTM D6319 00a (2005)e1, per ASTM D6124-06, per 21 CFR 800.20 and ISO 10993-10: 2002/Amd. 1: 2006.
The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
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.
Conclusions
It can be concluded that the Powder Free Nitrile Patient Examination Gloves, White Color 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 Nitrile Patient Examination Gloves, White Color is as safe, as effective, and performs as well as the predicate device, POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE, TANGSHAN ZHONGHONG PULIN GROUP CO., LTD.. K082598
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized lines representing its wings and body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Jiangsu Dongling Plastic Rubber Company Limited C/O Mr. Chu Xiaoan Beijing Easy-Link Company Limited Room 1606 Building 1 Jianxiang Yuan #209 Bei Si Huan Zhong Road Haidian District Beijing, PR China 100083
JUN 1 0 201
Re: K110248
Trade/Device Name: Powder-Free Nitrile Patient Examination Glove, White Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examnation Glove Regulatory Class: I Product Code: LZA Dated: May 26, 2011 Received: May 26, 2011
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,
Anthony D. asan
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
JiangSu DongLing Plastic & Rubber Co.,Ltd -Applicant:
510(k) Number (if known):_* K 110248
Device Name: Powder Free Nitrile Patient Examination Gloves, White Color
Indications For Use:
Powder Free Nitrile 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)
Elizabeth F. (Lawrie-Williams
(Division Sign-Off) · Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KIIO248 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.