(111 days)
Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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.
Powder Free Nitrile Patient Examination Gloves , Blue Color that meets all of the requirements of ASTM standard D 6139-10
This document is a 510(k) summary for a medical device called "Powder Free Nitrile Patient Examination Gloves, Blue Color." It aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 6139-10 | Meets |
| Physical Properties | ASTM standard D 6139-10 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-06 | <2mg/glove |
| Biocompatibility: Primary Skin Irritation | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| Biocompatibility: Dermal Sensitization | Dermal sensitization in the guinea pig | Passes (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample sizes used for the various tests.
The data provenance is not explicitly stated as retrospective or prospective, nor does it specify the country of origin of the data. However, the manufacturer is from China (Tangshan Zhonghong Pulin Plastic Co., Ltd., China), suggesting the testing might have been conducted there or through certified labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device. The testing involves adherence to established technical standards (ASTM, CFR, ISO) for physical properties and biocompatibility, not expert interpretation of diagnostic images or clinical outcomes. The "ground truth" is defined by the objective pass/fail criteria of these standards.
4. Adjudication Method for the Test Set
This information is not applicable to this device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or clinical events, not for standardized physical and chemical property testing of a product like examination gloves. The testing follows predefined methodologies within the cited standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted and is not relevant for this device. Such studies are typically performed for diagnostic or screening devices where human readers interpret results, often with AI assistance. This device is a patient examination glove, and its effectiveness is determined by its physical and biological properties.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study was not conducted and is not relevant for this device. This concept applies to AI/software algorithms. The "performance" of these gloves is their intrinsic material and functional characteristics, which are tested through laboratory methods.
7. Type of Ground Truth Used
The ground truth used for this device is based on established technical standards and regulatory requirements. Specifically:
- Physical properties (Dimension, Physical Properties, Freedom from pinholes, Powder Residual): Defined by the specified ASTM standards (D 6139-10, D 5250-06, D6124-06) and FDA regulation (21 CFR 800.20). The "ground truth" is whether the glove's measured properties fall within the acceptable ranges or thresholds defined by these standards.
- Biocompatibility: Defined by the results of specific animal tests (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) which have clear "Pass" criteria for demonstrating absence of irritation or sensitization. The ISO 10993-10 standard would outline the methodology and criteria for these tests.
8. Sample Size for the Training Set
This information is not applicable to this device. The concept of a "training set" belongs to machine learning and AI algorithms. The manufacturing process of gloves does not involve a training set in this context. The "training" for manufacturing would be the established quality control and production procedures.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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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."
KIZD970." (applicant leave blank) "The assigned 510(k) number is:
JUL 1 9 2012
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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 : | Tangshan Zhonghong Pulin Plastic Co., Ltd. | |
|---|---|---|
| Submitter's address : | Industrial Zone, Pachigang, Luannan, Tangshan, Hebei,063502, China | |
| Phone number : | (86)315-4169201 | |
| Fax number : | (86)315-4168700 | |
| Name of contact person: | Mr. ZHANG Liang | |
| Date the summary was prepared: | Jun.20th. 2012 |
[(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 Nitrile Patient Examination Gloves, Blue Color |
|---|---|
| Proprietary/Trade name: | Powder Free Nitrile Patient Examination Gloves, Blue Color |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LZA |
((a)(3)). An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* Nitrile Powder Free Patient Examination Gloves, Blue Color that meets all of the requirements of ASTM standard D 6139-10
Predicate device : Nitrile powder-free patient examination glove, JDA International Inc. K993247 .
[(a)(4)] A description of the device
Device Description: Powder Free Nitrile Patient Examination Gloves , Blue Color that meets all of the requirements of ASTM standard D 6139-10
-1/2- (rev.01)
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[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Nitrile Powder Free Patient Examination Gloves 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, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 6139-10 | Meets |
| Physical Properties | ASTM standard D 6139-10 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06and D6124-06 | <2mg/glove |
| Biocompatability | Primary Skin Irritation inrabbits | PassesNot a Primary Skin Irritation |
| Dermal sensitization in theguinea pig | 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 .
Nitrile powder-free patient examination glove meet requirements per ASTM D6319-10, per ASTM D6124-06, 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 Nitrile powder-free patient examination glove meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Chu Xiaoan Tangshan Zhonghong Pulin Plastic Company, Limited Room 1606 Building 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District. Beijing 100083, P.R. China
JUL 19 2012
Re: K120970
Trade/Device Name: Nitrile Powder Free Patient Examination Gloves, Colored (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 11, 2012 Received: July 11, 2012
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 yours,
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: TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD.
510(k) Number (if known): *
Device Name: _ Nitrile Powder Free Patient Examination Gloves, Coloured (Blue)
Indications For Use:
Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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 × (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)
B. P. Sletten
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120970
§ 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.