(100 days)
The Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The Powder Free Nitrile Examination Glove Class 1 patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-10.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Nitrile Examination Glove:
The provided document is a 510(k) summary for a medical device (Powder Free Nitrile Examination Glove) and an FDA clearance letter. It details how the device meets regulatory standards rather than outlining a traditional "study" in the sense of a clinical trial for diagnostic performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) | Meets ASTM D6319-10 |
| Physical Properties | Meets ASTM D0412-98 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension) | Meets ASTM D0412-98 |
| Freedom From Pin-holes | Meets ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves) | Meets ASTM D5151-06 |
| Powder Free Residue | Meets ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves) | Meets ASTM D6124-06 |
| Dermal Sensitization | Passed - Not a Dermal Sensitization (ASTM F720-81 (Reapproved 2007) - Standard Practice for Determining the Acute Toxicity of Materials) | Passed - Not a Dermal Sensitization (ASTM F720-81 (Reapproved 2007)) |
| Primary Skin Irritation | Passed - Not a Skin Irritant (Consumer Product Safety Commission, Title 16, Chapter II, Part 1500) | Passed - Not a Skin Irritant (Consumer Product Safety Commission, Title 16, Chapter II, Part 1500) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" and a "training set" in the context of machine learning or AI. Instead, it refers to testing conducted to meet specific ASTM standards and regulatory requirements for medical devices.
- Sample Size: Not explicitly stated for each test, but implied to be sufficient to meet the statistical requirements of the respective ASTM standards.
- Data Provenance: The origin of the data is not specified beyond indicating compliance with international ASTM standards and US regulatory bodies (FDA, Consumer Product Safety Commission). The nature of the testing is "non-clinical performance data," implying lab-based assessments of physical and biocompatibility characteristics, rather than patient data. The tests are prospective in the sense that they are performed on samples of the manufactured gloves to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable in the traditional sense for this type of device and study. The "ground truth" here is objective measurement against established physical and chemical standards (ASTM specifications, CPSC regulations). Experts would be involved in performing the tests and interpreting the results according to the standard protocols, but they are not "establishing ground truth" in the way, for example, a radiologist establishes ground truth for an image-based AI system.
4. Adjudication Method for the Test Set
Not applicable. The tests are based on objective measurements and compliance with predefined thresholds in standards, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology) where human-in-the-loop performance is being assessed. This document concerns a physical medical device (examination gloves) and its compliance with material and biocompatibility standards.
- Effect Size: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance assessment in the context of an "algorithm only" is not applicable here. This device is not an algorithm or an AI system. Its performance is inherent to its physical and chemical properties.
7. The Type of Ground Truth Used
The "ground truth" used is defined by:
- ASTM Standard Specifications: For dimensions, physical properties, freedom from pin-holes, and powder-free residue. These are quantitative and objective thresholds and methodologies described in the respective ASTM documents.
- Regulatory Guidelines/Standards: For biocompatibility tests (dermal sensitization, primary skin irritation), referencing ASTM F720 and Consumer Product Safety Commission regulations. These tests involve observing biological responses in animal models against predefined criteria for "irritant" or "sensitizer."
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI or machine learning model for this device. The manufacturing process and quality control ensure the device consistently meets the required specifications.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML model. The "ground truth," as described in point 7, is established by industry-wide recognized standards and regulatory requirements for medical gloves.
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SECTION 5
510(k) Summary
Date Prepared: 21ª Mar 2012
POWDER FREE NITRILE EXAMINATION GLOVE
| 5.1 | Submitter's Name: | Encompass Medical Supplies Inc Limited |
|---|---|---|
| 5.2 | Submitter's Address: | Hua Shen Road, Wai Gao Qiao Free Trade Zone,Shanghai 200131. |
| 5.3 | Contact No: | Tel: 0086-21-58666680 Fax: 0086-21-58666690 |
| 5.4 | Contact Person: | Mr. CJ AngTel: +60-19-5125422 |
| 5.5 | Name of Device: | Powder Free Nitrile Examination Glove, NonSterile (Blue Colored, Black Colored and WhiteColored) |
| Proprietary/Trade Name: | I) Powder Free Nitrile Examination GloveII) Other clients trade name and private labeling | |
| Common Name:Classification Name:Device Classification:Product Code: | Nitrile Examination GlovePatient Examination Glove (21 CER 880.6250)Class ILZA | |
| 5.6 | Predicate device: | Powder Free Nitrile Examination Gloves, White |
ldentification of The Legally Marketed Device: 5.7
The Powder Free Colored Nitrile Examination Glove Class I patient examination gloves, Nitrile-80 LZA, meets all of the requirements of ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.
Colored (K103734)
5.8 Description of Device:
The Powder Free Nitrile Examination Glove Class 1 patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-10.
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ENCOME ...
Intended Use of the Device: 5.9
The Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Summary of The Technological Characteristics of The Device: 5.10
The technological characteristics of Powder Free Nitrile Examination Glove (Blue Colored, Blacked Colored and White Colored) are summarized below as compared to ASTM requirements and to the predicate devices (K103734):
| Characteristic | Device Performance | Predicate Devices |
|---|---|---|
| Dimensions | Meets ASTM D6319-10 | Meets ASTM D6319-00a |
| Physical Properties | Meets ASTM D0412-98 | Meets ASTM D0412-98 |
| Freedom From pin-holes | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| Powder Free Residue | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| BiocompatibilityDermal Sensitization | Passed -Not a Dermal Sensitization(ASTM F720-81 (Reapproved 2007)) | Passed -Not a Dermal Sensitization(ASTM F720-81 (Reapproved 2007)) |
| Primary Skin Irritation | Passed - Not a Skin Irritant(Consumer product safety Commission,Title 16, Chapter II, Part 1500) | Passed - Not a Skin Irritant(Consumer product safety Commission,Title 16, Chapter II, Part 1500) |
Substantial Equivalent Based on Assessment of Non-Clinical 5.11 Performance Data
Testing performed per ASTM D6319-10 Standard Specification for Nitrile Examination Cloves for Medical Application and 21 CFR 800.20. Gloves meet all the current ASTM D 6319-10.
Primary skin irritation testing in the rabbit and delayed dermal contact sensitization study in the guinea pigs indicate no irritation or sensitization.
There are no special labeling claims and we do not claim our gloves to be hypoallergenic.
- Clinical Data: No clinical data was required. 5.12
5.13 Conclusion:
It can be concluded that the Powder Free Nitrite Examination Glove, Non Sterile (Blue Colored, Blacked Colored and White Colored) meet the ASTM standard or equivalent standard and FDA requirements.
Conclusively, we therefore claim that this device is substantially equivalent to its predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. CJ Ang Encompass Medical Supplies Inc Limited Hua Shen Road Wai Gao Oiao Free Zone Shanghai, China 200131
MAY - 2 2012
Re: K120184
Trade/Device Name: Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 13, 2012 Received: April 19, 2012
Dear Mr. Ang:
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. Ang
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. Mataur
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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SECTION 3 INDICATION FOR USE STATEMENT
INDICATIONS FOR USE 3.1
K120184 510(k) Number (if known): ___
Powder Free Nitrile Examination Gloves, Non Sterile (Blue Device Name: Colored, Black Colored and White Colored).
Indications For Use:
The Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Over-The-Counter Use × AND/OR Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Clarence-Willis
(Division Sign-Off) (Division Sign Siti)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
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210(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.