(42 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.
Powder Free Blue Patient Nitrile Examination Gloves that meets all of the requirements of ASTM D 6139-05
Acceptance Criteria and Device Performance Study
This document describes the acceptance criteria for the "Powder Free Blue Patient Nitrile Examination Gloves" and the study that demonstrates the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM D 6139-05 | Meets |
| Physical Properties | ASTM D 6139-05 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 5250-00c4 and D6124-01 | Meets |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO10993-10) | Passes (Not a Primary Skin Irritation) |
| Dermal sensitization in guinea pig (ISO10993-10) | Passes (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for each characteristic. However, the testing was conducted on the "Powder Free Blue Patient Nitrile Examination Gloves" manufactured by Tangshan Luxiong Plastic Products Co.,Ltd. The data provenance is not specified as retrospective or prospective, but it can be inferred that the testing was conducted specifically for this device as part of its premarket notification process. The country of origin of the device is China.
3. Number of Experts and their Qualifications for Ground Truth
The concept of "experts" and "ground truth" as typically applied to AI/ML device studies (e.g., radiologist consensus) is not directly applicable here. The device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards. Therefore, the "ground truth" is defined by these standards, and the "experts" would be the certified laboratories and personnel conducting the specified tests according to the standard operating procedures of each test. Their qualifications would be their certification and experience in performing these specific tests (e.g., in material science testing, biological safety testing).
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are not applicable to the testing of medical gloves against performance standards. The results of the tests (e.g., whether a dimension meets the specification, whether a sample passes the pinhole test) are objective measurements or categorical outcomes that do not require human interpretation or consensus in the same way as an image diagnosis. The "adjudication" is inherent in the methodology of the standard test itself, where specific pass/fail criteria are defined.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted medical devices where human readers interpret medical images or data. The "Powder Free Blue Patient Nitrile Examination Gloves" is a physical barrier device, and its effectiveness is determined by its physical and biological properties.
6. Standalone Performance (Algorithm Only)
A standalone performance study (algorithm only) was not done. This device is not an algorithm or AI system. Its performance is entirely physical and biological, as assessed through laboratory testing.
7. Type of Ground Truth Used
The type of ground truth used is based on established industry standards and regulatory requirements. Specifically:
- ASTM D 6139-05: For Dimension and Physical Properties.
- 21 CFR 800.20: For Freedom from pinholes.
- ASTM D 5250-00c4 and D6124-01: For Powder Residual.
- ISO10993-10: For Biocompatibility (Primary Skin Irritation and Dermal sensitization).
These standards define the methodologies, acceptance criteria, and expected performance for patient examination gloves.
8. Sample Size for the Training Set
A "training set" is not applicable to this device. This is not an AI/ML device that requires machine learning model training. The device's manufacturing process is controlled to meet the specified standards, and batches are tested to ensure compliance.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML model, the concept of establishing ground truth for a training set is not relevant here. The "ground truth" for the device's performance is inherently defined by the objective, predetermined pass/fail criteria within the ASTM and ISO standards mentioned above. These standards are developed through expert consensus within their respective organizations (ASTM, ISO) and are widely accepted in the industry and by regulatory bodies.
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Summary
MAR 2 6 2007
"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: ______________________________________________________________________________________________________________________________________________
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 Luxiong Plastic Products Co.,Ltd |
|---|---|
| Submitter's address : | Industrial Zone, Tanghai County, Tangshan,Hebei , 063200, P. R. China |
| Phone number : | (86)315-4169201 |
| Fax number : | (86)315-4169311 |
| Name of contact person: | Ms. Zhang Liang |
| Date the summary was prepared: | Feb.09.2007 |
[(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 Blue Patient Nitrile Examination Gloves |
|---|---|
| Proprietary/Trade name: | Powder Free Blue Patient Nitrile Examination Gloves |
| 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* Powder Free Blue Patient Nitrile Examination Gloves that meets all of the requirements of ASTM D 6139-05
Predicate device : Nitrile powder-free patient examination glove, JDA International Inc. K993247 .
|(a)(4){ A description of the device
Device Description : Powder Free Blue Patient Nitrile Examination Gloves that meets all of the requirements of ASTM D 6139-05
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[(a)(5)] The summary describes the intended use of the device
Device Intended 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.
[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The Powder Free Blue Patient Nitrile Examination Gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM D 6139-05 | Meets |
| Physical Properties | ASTM D 6139-05 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 5250-00c4and D6124-01 | Meets |
| 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 .
Powder Free Blue Patient Nitrile Examination Gloves 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 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 Powder Free Blue Patient Nitrile Examination Gloves 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 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2007
Mr. Chu Xiaoan Official Correspondent Tangshan Luxiong Plastic Products Company, Limited Room 1606 Building 1, Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District Beijing, China 100083
Re: K070404
Trade/Device Name: Nitrile Powder Free Blue Patient Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: February 9, 2007 Received: February 12, 2007
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 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); 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. 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 Luxiong Plastic Products 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)
Shule P. Murphy, M.D.
18 22 22 12 ം പങ്ങു Hospilal 3. 1964
- Number K07040
§ 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.