(58 days)
Not Found
No
The document describes a standard patient examination glove and its testing against established ASTM and FDA standards. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The device, a patient examination glove, is intended to prevent contamination and is classified as Class I, neither of which are characteristics of a therapeutic device.
No.
The device is a patient examination glove, intended to prevent contamination between healthcare personnel and patients. Its purpose is protective, not diagnostic.
No
The device description clearly identifies the device as a physical patient examination glove, which is a hardware component. The summary discusses physical testing and material properties, not software functionality.
No, 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's body, fluids, waste, or environment. This is a barrier device for physical protection.
- Device Description: The description classifies it as a Class I device 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: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers or analytes
The device's function is purely as a physical barrier, which is not the purpose of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination gloves is a disposable device intended for medical purposes that is worn 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
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 , powdered with Absorbable Dusting Powder, USP, Class III 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
Not Found
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 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 Iodine Test methodology and testing "powder-residue 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SHANGHAI GLOVMAX ENTERPRISE CO., LTD.
Song Jiang Industrial Zone, Che Dun Branch Zone, Rong Chang Rd., #2, Shanghai, China C/O: Room B, 11F, No. 201, Nanking E. Rd., Sec.3, Taipei, Taiwan, R.O.C.
JAN 1 2 2000
TEL: 886-2-25462479 FAX: 886-2-25147612
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:
1.Submitter's Identification:
Mr. Mao-Sheng Lee SHANGHAI GLOVMAX ENTERPRISE CO., LTD. Song Jiang Industrial Zone, Che Dun Branch Zone, Rong Chang Rd., #2, Shanghai, China
Date Summary Prepared: Nov. 5, 1999
2.Name of the Device:
SHANGHAI GLOVMAX ENTERPRISE CO., LTD. Powder-free Vinyl Examination Gloves
3. Predicate Device Information:
Shanghai Huamao Gloves Co., Ltd. #K984460
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 , powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
5.Intended Use:
A patient examination gloves is a disposable device intended for medical purposes that is worn 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 GLOVMAX ENTERPRISE CO., LTD.
Song Jiang Industrial Zone, Che Dun Branch Zone, Rong Chang Rd., #2, Shanghai, China C/O: Room B, 11F, No. 201, Nanking E. Rd., Sec.3, Taipei, Taiwan, R.O.C.
TEL: 886-2-25462479 FAX: 886-2-25147612
6.Comparison to Predicate devices:
SHANGHAI GLOVMAX ENTERPRISE CO., LTD. Powder-free Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shanghai Huamao 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 GLOVMAX ENTERPRISE 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 Iodine Test methodology and testing "powder-residue 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 not hypoallergenic claim.
9.Conclusions:
SHANGHAI GLOVMAX ENTERPRISE 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.
ATTACHMENT B. PAGE 2 OF 2
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus symbol with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2000
Mr. Mao-Shenq Lee, President Shanghai Glovmax Enterprise Co., Ltd. Room B, 11th Floor, No. 201
Nanking E. Road, Sec. 3 Taipei, Taiwan, R.O.C.
Re : K993880 Shanghai Glovmax Enterprise Co., Ltd. Trade Name: Powder-Free Vinyl Patient Examination Gloves Requlatory Class: I Product Code: LYZ Dated: November 5, 1999 Received: November 15, 1999
Dear Mr. Lee:
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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ 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
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Page 2 - Mr. Lee
obligation you might have under sections 531 through 542 of 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 requlation 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
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT A
Page __ 1__ of _ 1
510(k) number (if known): 943880
Shanghai Glovmax Enterprise Co., Ltd. Device name: Powder-free Vinyl 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Qun S. Lim
ental. Infection Control, 510/k) Numb