(55 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a patient examination glove, with no mention of AI or ML.
No
The device is a patient examination glove, which is intended to prevent contamination rather than treat a disease or condition.
No
A patient examination glove is a barrier device used to prevent contamination, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly identifies the device as a physical patient examination glove, which is a hardware device, not software.
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 "patient examination glove" worn on the hand to prevent contamination between healthcare personnel and the patient. This is a barrier device for physical protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: It's classified as Class I under 21 CFR 880.6250, which is for "Patient Examination Glove." This classification is for general and plastic surgery devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The testing described focuses on the physical properties and barrier function of the glove.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide medical information. This glove's function is purely as a physical barrier.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worr on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A 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.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250. Powder-free Vinyl Patient Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
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 standards used for SHANGHAI HUAMAO GLOVES CO., LTD. Production are based on ASTM D-5250-92. All 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 S-4, meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
A USP Iodine Test for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free" claim. We adhere to all USP lodine Test methodology and testing "powderresidue by weight" and are contracting with a laboratory to conduct particulate testing for added assurance. Final release testing consists of a light transmission test using a spectrophotometer.
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
FEB - 9 1999
球网
SHANGHAI HUAMAO GLOVES CO., LTD.
No. 8, New Industrial Area, Zhu Hang Zhen, Jin Shan County, Shanghai, China C/O: Room C, 11F, 201, Nanking E Rd., Sec. 3, Taipei, Taiwan, R.O.C. Tel/Fax: 886-2-2712-5051
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
The assigned 510(k) number is : K984460
1.Submitter's Identification:
Mr. Hsieh, I-shih SHANGHAI HUAMAO GLOVES CO., LTD. No. 8, New Industrial Area, Zhu Hang Zhen, Jin Shan County, Shanghai, China
Date Summary Prepared: 27 November 1998
2. Name of the Device:
SHANGHAI HUAMAO GLOVES CO., LTD. Powder-free Vinyl Patient Examination Gloves
3. Predicate Device Information:
Shanghai Super Gloves Co., Ltd. #K974120
4. Device Description:
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250. Powder-free Vinyl Patient Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.
5.Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worr on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
1
SHANGHAI HUAMAO GLOVES CO., LTD.
No. 8, New Industrial Area, Zhu Hang Zhen, Jin Shan County, Shanghai, China C/O: Room C, 11F, 201, Nanking E Rd., Sec. 3, Taipei, Taiwan, R.O.C. Tel/Fax: 886-2-2712-5051
6. Comparison to Predicate devices:
SHANGHAI HUAMAO GLOVES CO., LTD. Powder-free Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shanghai Super Gloves Co., Ltd. Powder-free vinyl patient examination Gloves.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for SHANGHAI HUAMAO GLOVES CO., LTD. Production are based on ASTM D-5250-92. All 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 S-4, meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
A USP Iodine Test for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free" claim. We adhere to all USP lodine Test methodology and testing "powderresidue by weight" and are contracting with a laboratory to conduct particulate testing for added assurance. Final release testing consists of a light transmission test using a spectrophotometer.
8.Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic claim.
9.Conclusions:
11:11
SHANGHAI HUAMAO GLOVES CO., LTD. Vinyl Patient Examination Gloves conform fully to ASTM D-5250-92 standards as well as applicable 21 CFR references, and meets pinhole FDA requirements, bio-compatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the " substantial equivalence" products cited.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the upper half of the circle. Inside the circle is a stylized symbol that resembles three overlapping human profiles facing to the right. The symbol is rendered in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 1999
Shanghai Huamao Gloves Co. Ltd. C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
K984460 Re : Powder-Free Vinyl Patient Examination Gloves Trade Name: Regulatory Class: I Product Code: LYZ Dated: December 14, 1998 Received: December 16, 1998
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
3
Page 2 - Ms. Goldstein-Falk
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exhibit A
Page 1 ot
510(k) NUMBER (IF KNOWN): K984460
SHANGHAI HUAMAO GLOVES CO., LTD. Powder-free Vinyl Patient DEVICE NAME: Examination Gloves INDICATIONS FOR USE:
A 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use $\underline{X}$
(Optional Format 1-2-96)
Olin Si Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 510(k) Number