(89 days)
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML.
No
The device is a non-sterile, powder-free nitrile examination glove, intended to prevent contamination between patient and examiner. It is a barrier device, not designed to provide therapy or treatment for a condition.
No
The device, "Non-sterile Powder Free Black Nitrile Examination Gloves," is intended to prevent contamination between patient and examiner, not to diagnose a medical condition.
No
The device is a physical medical device (examination gloves) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and standards met by examination gloves (ASTM D6319, ISO 2859-1, etc.). These standards are relevant to the performance and safety of gloves as a barrier, not for diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a medical device used for protection and examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand of the health care personnel; examiner's hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care and similar personnel; examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
-
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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.
-
- 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.
2
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.
3
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
4
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