(89 days)
The Non-sterile Powder Free Black Nitrile Examination Gloves with Cherry Flavor, 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.
Doves I Nitrile examination gloves 80LZA, powder free and meeting all the requirements of ASTM D6319-00a (2005) Standard Specification for Nitrile Examination Gloves for Medical Application.
This document describes the acceptance criteria and the study proving the device meets those criteria for Non-Sterile, Powder Free Black Nitrile Examination Gloves with Cherry Flavor.
It's important to note that this is a premarket notification (510(k)) for a Class I medical device (patient examination glove). The "study" here refers to demonstrating compliance with established performance standards and biocompatibility testing, rather than a clinical trial with human subjects in the way one might think of for more complex medical devices or pharmaceuticals.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Standard/Test | Reported Device Performance (as implied by "meets" or "equivalent") |
|---|---|
| ASTM D6319-00a(2005) | Met: Standard Specification for Nitrile Gloves. |
| ISO 2859-1 (Water Leak Test) | Met: Standard for Water Leak Test. |
| ASTM D5151-06 (Hole Detection) | Met: Test Method for Detection of Holes in Medical Gloves (alternative to ISO 2859-1). |
| ASTM D6124-06 | Met: Standard Test Method for Residual Powder on Medical Gloves. |
| Biocompatibility Testing | Met: Testing performed on White Rabbits and Guinea Pigs. |
| Labeling | Met: FDA Specifications. |
| Equivalence to K072400 | Met: Except for the cherry flavor, this glove is equivalent to the predicate device K072400 (POWDER FREE BLACK NITRILE EXAM GLOVES). |
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 water leak, number of residual powder tests). However, for standards like ISO 2859-1, specific sampling plans (sample sizes and acceptable quality limits - AQLs) are defined within the standard itself for batch testing.
The data provenance is from Thailand (SGMP Company Limited is in Thailand). The data is retrospective in the sense that the testing was conducted prior to submission for regulatory clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of submission for examination gloves does not typically involve "experts" establishing a "ground truth" in the clinical sense (e.g., radiologists interpreting images). Instead, the "ground truth" is adherence to the performance specifications defined by the ASTM and ISO standards themselves. The "experts" involved would be the qualified laboratory personnel performing the standardized tests according to the written protocol of each standard. Their qualifications would be in laboratory practices, quality control, and the specific test methodologies. The number of such personnel is not specified.
4. Adjudication Method
Not applicable for this type of device and testing. Test results against established standards do not typically involve adjudication among multiple human readers. Outcomes are binary: pass/fail the standard's defined limits.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not the type of device where MRMC studies are performed. MRMC studies are typically for diagnostic imaging devices where human interpretation is a key component.
6. Standalone Performance Study
Yes, in a sense. The compliance with ASTM and ISO standards demonstrates the standalone performance of the device (the glove itself, without a human "in-the-loop" in the way an AI diagnostic tool would have). The biocompatibility testing also evaluates the standalone biological performance of the glove material.
7. Type of Ground Truth Used
The ground truth used is primarily performance specifications defined by internationally recognized standards (ASTM and ISO), along with biocompatibility testing results.
- ASTM D6319-00a(2005): Defines physical properties (e.g., tensile strength, elongation, force at break) for nitrile examination gloves.
- ISO 2859-1 / ASTM D5151-06: Specifies acceptable levels of pinholes in gloves.
- ASTM D6124-06: Specifies limits for residual powder.
- Biocompatibility Testing: Involves a series of tests (often based on ISO 10993 standards, though not explicitly stated here for gloves) to assess the biological response to the device, conducted on animals (White Rabbits and Guinea Pigs).
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm requiring a "training set." The testing performed is to demonstrate compliance of manufactured batches with established performance standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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SEP 0 8 2010
APPENDIX M
510(k) SUMMARY
SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR .
Submitted For : SGMP Company Limited, 181 Moo 6, Tambol Kampaengpetch, Rattaphum, Songkhla 90180, Thailand.
Submitted By: Tucker & Associates Official Correspondent for SGMP Co Ltd Janna P. Tucker, President - CEO 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: POWDER FREE BLACK NITRILE EXAM GLOVES which was granted a 510(k) # K072400
Device Information:
Trade Name - Non-Sterile, Powder Free Black Nitrile Examination Gloves with Cherry Flavor 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 D6319-00a (2005) Standard Specification for Nitrile Examination Gloves for Medical Application.
Device Description:
Doves I Nitrile examination gloves 80LZA, powder free and meeting all the requirements of ASTM D6319-00a (2005) 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 personnel to prevent contamination between health care personnel and patient.
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PAGE 2, APPENDIX M
Conclusion:
The data presented indicate the Non-Sterile, Powder-Free Black Nitrile Examination Gloves with Cherry Flavor meets the following Standards:
-
- ASTM D6319-00a00a(2005), Standard Specification for Nitrile Gloves.
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- ISO 2859-1, Standard for Water Leak Test and/or ASTM D5151-06, Test Method for Detection of Holes in Medical Gloves.
-
- ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves.
-
- Biocompatibility Testing on White Rabbits and Guinea Pigs.
-
- Labeling meets FDA Specifications.
-
- Except for flavor, this glove is equivalent to K072400.
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Image /page/2/Picture/0 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo is divided into two parts by a dotted line. On the left side, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion. On the right side, there is a stylized graphic of what appears to be three overlapping human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SGMP Company, Limited C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'Emerald Sparks, Nevada 89434
Re: K101646
Trade/Device Name: Non-Sterile, Powder Free Black Nitrile Examination Gloves with Cherry Flavor Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 10, 2010 Received: June 11, 2010
SEP 0 8 2010
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. 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- 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); 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.
1f 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 vours.
Th for
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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INDICATION FOR USE STATEMENT
SEP 0 8 2010
Applicant : SGMP Company Limited
510K NUMBER :
Device Name : Non-Sterile, Powder Free Black Nitrile Examination Gloves with Cherry Flavor
Indication For Use :
The Non-sterile Powder Free Black Nitrile Examination Gloves with Cherry Flavor, 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)
Elizabeth F. Clavie-Williams
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
510(k) Number: K101646
§ 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.