(213 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML technology.
No
The device is a non-sterile examination glove intended to prevent contamination, not to treat or cure a disease or condition.
No
The device is described as a disposable glove intended to prevent contamination between patient and examiner, not to diagnose a condition. Its conformity to standards like ASTM D6319-00aE3 confirms its suitability as a medical glove, not a diagnostic tool.
No
The device is a physical medical device (examination gloves) and the summary describes hardware standards and testing, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a barrier device worn on the hand or finger to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on samples from the body.
- Device Description: The description focuses on the material (nitrile), class (Class I), and adherence to standards for examination gloves. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostics.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
The device is a medical glove, which is a Class I medical device used for protection and barrier purposes.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care and similar porsomnel
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 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.
-
- Labeling meets FDA Specifications
-
- Except for Color, this glove is equivalent to K000868.
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
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.
Page 1 of 2
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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
Page 2 of 2
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
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.
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); 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
4
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