(61 days)
Not Found
Not Found
No
The device is a patient examination glove, a simple barrier device with no mention of AI/ML in its description or testing.
No
The device is a patient examination glove, intended to prevent contamination, not to provide therapy.
No
Explanation: The device description clearly states "A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This indicates its purpose is as a barrier for contamination, not for diagnosing medical conditions.
No
The device is a patient examination glove, which is a physical hardware device made of plastic. The description focuses on material properties, physical dimensions, and performance tests related to the glove itself, not software functionality.
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 a "disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control, not a device used to examine specimens taken from the human body.
- Device Description: The classification as a "Patient Examination Glove" under 21 CFR §880.6250 further confirms its purpose as a physical barrier.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
The device's function is purely mechanical – providing a physical barrier. This is not the function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is disposable device intended for medical purpose 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)
LYZ
Device Description
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 Classince by IDA's General Froopmatient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Tests Performed: The standards used 107 Grand 11 of testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 4.0. The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level I, meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing i rinal Found frinances and showing no primary skin irritant or sensitization reactions. A Residual Powder Test that based on ASTM D-6124-06 for powder at finished A Resultude Fowder Test mat our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
Clinical Tests Performed: Not Applicable - There is no hypoallergenic Claim.
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.
Better Care Plastic Products Co., Ltd Dettor Care Frastic Product Comination Gloves, (Yellow, White, Blue, Pink)
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.
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OCT 5 2010
EXHIBIT #1 Page 1 of 2
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(K) number is: K102094
l. Owner's Identification:
Ms. Yuli Wu Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, China 050000 Date Summary Prepared: June 7, 2010
- Name of the Device:
Grand Work Plastic Products Co., Ltd. Stand Work Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink)
3. Predicate Device Information:
Better Care Plastic Products Co., Ltd Dettor Care Frastic Product Comination Gloves, (Yellow, White, Blue, Pink)
4. Device Description:
. Device Description:
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 Classince by IDA's General Froopmatient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
5. Intended Use:
A patient examination glove is disposable device intended for medical purpose that A patient exammation grove is disposers as not on and or between patient and examiner.
6. Comparison to Predicate Devices:
Grand Work Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink) is substantially equivalent in safety and Oloves, ( I chow, Winter, Blastic Products Co., Ltd's Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink).
1
EXHIBIT #1 Page 2 of 2
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
Equivalence are as For Grand Work Plastic Products Co., Ltd.'s glove production are The standards used 107 Grand 11 of testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 4.0.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level I, meeting these requirements.
Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing i rinal Found frinances and showing no primary skin irritant or sensitization reactions.
A Residual Powder Test that based on ASTM D-6124-06 for powder at finished A Resultude Fowder Test mat our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
8. Labeling:
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
9. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
10. Conclusions:
Grand Work Plastic Products Co., Ltd.'s Powder Free Viryl Patient Examination Gloves, (Yellow, White, Blue, Pink) conform fully to ASTM D-5250-06e1 standard Gloves, ( Fenow, Willic, Diac, I mic) commonly and meets pinhole FDA requirements, as well as applicable 2 P OF ICTOrereless, and labeling claims as shown by data in Section 7.
biocompatibility requirements and labeling claims as shown by data tick olocompatibility requirements and on new claims from the "substantial I here are no safety/citicacy issues of how claim mentioned is as safe, as effective, and performs as well as or better than the predicate device.
2
Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Grand Work Plastic Products Company, Limited C/O Ms. Kathy Liu Surprotect, Incorporated Donggao Industrial Zone Zanhuang, Hebei CHINA 050000
OCT 5 2010
Re: K102094
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 7, 2010 Received: July 27, 2010
Dear Ms. Liu;
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. Liu
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,
ﮐﯽ ﻣﯿﮟ ﻭﺍﻗﻊ ﮨﮯ۔
ﺍﺱ ﮐﯽ ﻣ
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
Attachment A
INDICATION FOR USE
510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:
K102094 Grand Work Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink)
INDICATIONS FOR USE:
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Elizabetth. F. Clavere-wells
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _ K 102094
Prescription Use (Part 21 CFR 801 Subpart D) AND/ OR
Over-The-Counter-Use _ 2 (21CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)