(121 days)
Powder Free Blue Patient Nitrile 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.
Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6319-05
The provided document describes the acceptance criteria and the study conducted for the Nitrile Powder Free Patient Examination Gloves (Blue). This is a medical device subject to regulatory clearance, and the study focuses on non-clinical performance to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 6319-05 | Meets |
| Physical Properties | ASTM standard D 6319-05 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-01 | < 2 mg/glove |
| Biocompatibility: Primary Skin Irritation | Per ISO10993-10 / Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| Biocompatibility: Dermal Sensitization | Per ISO10993-10 / Dermal sensitization in the guinea pig | 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 each specific test (e.g., number of gloves tested for dimension, physical properties, or pinholes). However, the tests are conducted as per ASTM standard D 6319-05, 21 CFR 800.20, ASTM standard D 5250-06, D6124-01, and ISO10993-10. These standards typically define the sampling plans and statistical methods for evaluating product quality.
Most of these tests are likely retrospective in the sense that they are performed on manufactured batches of the device. The data provenance is from China, where the manufacturer (TANGSHAN ZHONGHONG PULIN GROUP CO., LTD.) is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (patient examination gloves) and the nature of the tests performed do not typically involve human experts to establish ground truth in the way an AI diagnostic algorithm would. The "ground truth" for these tests is defined by objective, measurable laboratory standards (e.g., specific dimensions, tensile strength measurements, water leak test results, chemical analysis for powder, animal model responses for biocompatibility). These are evaluated by trained laboratory personnel following standardized protocols, not by clinical "experts" in the traditional sense of clinicians establishing a diagnosis.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, often when humans are interpreting images or clinical data. Since the tests for this device are objective and based on established industry standards and laboratory procedures, no formal adjudication method is mentioned or typically needed. The results are quantitative measurements or pass/fail criteria against pre-defined thresholds.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is typically conducted for diagnostic or AI-assisted interpretation devices where human performance is a key factor, often involving multiple radiologists or clinicians evaluating cases with and without AI assistance to measure improvement in accuracy or efficiency. Patient examination gloves are a much simpler device, evaluated for basic physical properties and biocompatibility.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone study was done. This concept is specifically relevant to AI/ML algorithms, where the algorithm's performance is evaluated independently of human interaction. Since the device in question is a physical product (gloves) and not a software algorithm, this type of study is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Objective laboratory measurements: for characteristics like dimension, physical properties (e.g., tensile strength, elongation), and powder residual.
- Standardized test methods: for "freedom from pinholes" (water leak test).
- Animal model studies: for biocompatibility (primary skin irritation in rabbits and dermal sensitization in guinea pigs).
There is no "expert consensus," "pathology," or "outcomes data" in the clinical sense used to establish ground truth for these non-clinical performance metrics.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. Training sets are used in machine learning for developing AI algorithms. This device is a physical product being evaluated against engineering and biological performance standards, not an AI model.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this device, the question of how its ground truth was established is not applicable.
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Summary
KOR2598
JAN - 7 2009
"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 :
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. 35 SONGHE ST, BENCHENG, LUANNAN COUNTY TANGSHAN, Submitter's address : HEBEI, 063500, CHINA (86)315-4169201 Phone number : Fax number . (86)315-4168700 Name of contact person: Ms. Zhao Ruiyou Oct.31.2008 Date the summary was prepared:
[(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
Nitrile Powder Free Patient Examination Gloves (Blue) Device Name: Nitrile Powder Free Patient Examination Gloves( Blue) Proprietary/Trade name: Patient examination glove Common Name: Patient examination glove Classification Name: Device Classification: I Regulation Number: 21 CFR 880.6250 General Hospital (80) Panel: LZA Product Code:
[(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 that meets all of the requirements of ASTM standard D 6319-05
Predicate device : Nitrile powder-free patient examination glove, JDA International Inc. K993247 .
[(a)(4)] A description of the device
Device Description : Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6319-05
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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 6319-05 | Meets |
| Physical Properties | ASTM standard D 6319-05 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06and D6124-01 | <2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbits | PassesNot a Primary Skin Irritation |
| Dermal sensitization in the guinea 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 D6319-05, 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 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
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tangshan Zhonghong Pulin Group Company, Limited C/o Mr. Chu Xiaoan Official Correspondent Room 1606 Building 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing 100083, P.R. China
JAN - 7 2009
Re: K082598
Trade/Device Name: Powder Free Blue Patient Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 15, 2008 Received: December 19, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations asffecting 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 mcan 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Ccnter for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Smarrunner
Ginette Miskand, MD
Ginette Michaud, MD Acting 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 GROUP CO.,LTD.
510(k) Number (if known) _*
Device Name: Powder Free Blue Patient Nitrile Examination Gloves
Indications For Use:
Powder Free Blue Patient Nitrile 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.
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)
Shula W. Murphy, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:__
2398
§ 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.