(213 days)
The Non-sterile Powder Free Black 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.
Class I Nitrile examination gloves 80LZA, powder free and meeting all the requirements of ASTM D6319-00aE3 Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document describes the safety and effectiveness summary for Non-Sterile, Powder Free Black Nitrile Examination Gloves, which are classified as a Class I medical device. The document focuses on demonstrating substantial equivalence to a predicate device (K000868) by meeting established industry standards for examination gloves.
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
| Acceptance Criteria / Standard | Required Performance | Reported Device Performance | Study Type/Method |
|---|---|---|---|
| ASTM D6319-00aE3, Standard Specification For Nitrile Gloves. | Meeting all requirements of ASTM D6319-00aE3 | Meets the requirements of ASTM D6319-00aE3 | Implied through compliance statement. Specific tests include: - Tensile Strength - Elongation - Dimensions (Length, Palm Width, Finger Thickness) |
| 1SO 2859-1, Standard for Water Leak Test and/or ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves. | Detection of holes in medical gloves | Meets the requirements of ISO 2859-1 and/or ASTM D5151-06 (Water Leak Test) | Water Leak Test (specifics of sample size/method not detailed beyond standard reference) |
| ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves. | Measurement of residual powder | Meets the requirements of ASTM D6124-06 (Residual Powder Test) | Residual Powder Test (specifics of sample size/method not detailed beyond standard reference) |
| Biocompatibility Testing | Biocompatibility on White rabbits and Guinea pigs (absence of irritation/sensitization) | Meets Biocompatibility Testing on White rabbits and Guinea Pigs | Biocompatibility testing (specifics of tests/sample size not detailed beyond animal models) |
| Labeling | Meets FDA Specifications | Meets FDA Specifications | Labeling review against FDA guidelines |
| Equivalence to Predicate Device (K000868) | Substantially equivalent to K000868 (except for color) | Substantially equivalent to K000868 (except for color) | Comparative review against predicate device specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., water leak, residual powder, tensile strength). It refers to compliance with the standards, implying that the sample sizes and methods prescribed within those standards were followed.
- Data Provenance: The manufacturing company is based in Thailand (SGMP Company Limited, 181 Moo 6, Tambol Kampacngpotch, Rattaphum, Songkhla 90180, Thailand). It is likely that the testing data was generated in Thailand or by laboratories compliant with international standards, but the exact country of origin for the data is not explicitly stated. The studies are retrospective in the sense that they were conducted on the manufactured product to demonstrate compliance with existing standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in this context. The "ground truth" for medical gloves is established by meeting predefined physical and chemical performance standards (e.g., ASTM, ISO standards) rather than by expert clinical consensus or interpretation of diagnostic images. The standards themselves define the acceptable parameters for mechanical properties, barrier integrity, and biocompatibility.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication typically refers to resolving discrepancies in expert opinions, which is not relevant for testing physical properties of a device against objective standards. The outcome of the tests (e.g., does it leak or not, what is the tensile strength) is typically a quantifiable measurement or a pass/fail determination based on predefined thresholds in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The device is a physical medical glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical glove, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of these gloves is defined by:
- Performance Standards: The specifications outlined in ASTM D6319-00aE3, ISO 2859-1, ASTM D5151-06, and ASTM D6124-06. These standards define the acceptable physical properties (e.g., tensile strength, elongation), barrier integrity (water leak test), and chemical characteristics (residual powder).
- Biocompatibility Standards: Established protocols for testing biological reactions on animal models (White rabbits and Guinea pigs).
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not a machine learning model. There is no "training set." The manufacturing process is subject to quality control, and batches of gloves are sampled for testing against the standards.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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MAR 2 7 2008
APPENDIX K
K072400 510(k) SUMMARY SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES
Submitted For : SGMP Company Limited, 181 Moo 6, Tambol Kampacngpotch, Rattaphum, Songkhla 90180, Thailand.
Tucker & Associates Submitted By: Official Correspondent for SGMP Co Ltd Janna P. Tucker, President - CRO 198 Avenue de la D'emerald, Sparks, NV 89434-9550 Phone No : 775-342-2612 Fax No : 775-342-2613 E-mail: Tuckerjan@aol.com
Equivalent Predicate Device: PQWDER FREE BLUE NITRILE EXAM GLOVES which was granted a 510(k) # K000868
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Device Information:
Trade Name - Non-Sterile, Powder Free Black Nitrile Exammation Gloves
Common Name - Exam gloves
Classification Name - Patient examination glove (per 21 CFR 880.6250)
Classification Information - Class I Nitrile examination glove 80LZA, powder free and meeting all the requirements of ASTM D6319-00aE3 Standard Specification for Nitrile Examination Gloves for Medical Application.
Device Description:
Class I Nitrile examination gloves 80LZA, powder free and meeting all the requirements of ASTM D6319-00aE3 Standard Specification for Nitrile Examination Gloves for Medical Application.
Intended Use of Device:
A medical glove to be worn on the hand of the health care and similar porsomnel to prevent contamination between health care personnel and patient.
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Image /page/1/Picture/0 description: The image shows a handwritten alphanumeric string. The string appears to be "KO72400". The characters are written in a simple, slightly irregular style, giving the impression of casual handwriting.
Conclusion:
The data presented indicate the Non-sterile Powder-Free Black Nitrile Examination Glove meets the following Standards:
- ASTM D6319-00aE3, Standard Specification For Nitrile Gloves. 】.
- 1SO 2859-1, Standard for Water Leak Test and/or ASTM D5151-06, Standard Test Method for 2. Detection of Holes in Medical Gloves.
-
- ASTM D6124-06, Sundard Test Method for Residual Powder on Medical Gloves.
-
- Biocompatibility Testing on White rabbits and Guinea Pigs.
- ડ. Labeling meets FDA Specifications
- હ. Except for Color, this glove is equivalent to K000868.
APPENDIX K
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion and an abstract symbol resembling an eagle or a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the left side of the logo. The abstract symbol is on the right side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2008
SGMP Company, Limited C/O Ms. Janna P. Tucker Official Correspondent/ United States Agent Tucker & Associates 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550
Re: K072400
Trade/Device Name: Non-Sterile, Powder Free Black Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: March 11, 2008 Received: March 13, 2008
Dear Ms. Tucker:
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 Eederal Register.
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Page 2 - Ms. Tucker
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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INDICATION FOR USE STATEMENT
Applicant : SGMP Company Limited
510K NUMBER Dr
11072400
Device Name : Non-Sterile, Powder Free Black Nitrile Examination Gloves
Indication For Use :
The Non-sterile Powder Free Black 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 .... 21 CFR 801 Subpart C
.............................................................................................................................................................................. Concurrence of CDRH , Office of Device Evaluation (ODE)
Sheila H. Murphy, KD
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072400
§ 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.