(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 glove intended to prevent contamination between healthcare personnel and patients, not to treat a disease or condition for therapeutic benefit.
No
The device is a patient examination glove, intended to prevent contamination between healthcare personnel/examiner and the patient. It does not collect or analyze data to provide information about a patient's health or disease.
No
The device description clearly identifies the device as a physical glove, a hardware component, and the performance studies focus on physical properties and testing of the glove material. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is worn on the hand to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment. This is a barrier function, not a diagnostic function.
- Device Description: The device is classified as a "Pre-powder Vinyl Patient Examination Glove." This classification is for a physical barrier device.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (like blood, urine, tissue) or to provide information about a patient's health status or condition. IVDs are specifically designed for these purposes.
- Performance Studies: The performance studies focus on physical properties (dimensions, water fill test) and biocompatibility (skin irritation/sensitization), which are relevant for a barrier device, not a diagnostic one.
The device is a medical device, but it falls under the category of a barrier device used for infection control, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A glove 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
80LYZ
Device Description
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Pre-powder 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
hand or finger
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.
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.
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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 : K984461
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. Pre-powder Vinyl Examination Gloves
3. Predicate Device Information:
Shanghai Super Gloves Co., Ltd. #K974151
4. Device Description:
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Pre-powder 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 glove 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 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. Pre-powder Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shanghai Super Gloves Co., Ltd. Pre-powder 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.
SHANGHAI HUAMAO GLOVES CO., LTD. Operates in compliance with FDA's GMPs.
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic claim.
9.Conclusions:
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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, represented by three curved lines that suggest the bird's head and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 1999 FEB
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
Re: K984461 Pre-Powder-Free Vinyl Patient Examination Trade Name: Gloves Requlatory Class: I Product Code: LYZ December 14, 1998 Dated: 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation 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
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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 regulation (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 qeneral 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
Timothy A. Ulatows Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
Exhibit A
Page of
| 510(k) NUMBER (IF KNOWN): | K984461 |
|---|---|
| DEVICE NAME: | SHANGHAI HUAMAO GLOVES CO., LTD. Pre-Powder Vinyl Patient 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
(Optional Format 1-2-96)
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number