(213 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML.
No
The device, a Powder-Free Nitrile Examination Glove, is intended to prevent contamination between patient and examiner, serving as a barrier, not to treat or cure a disease or condition.
No
This device is a glove, intended to prevent contamination between a patient and an examiner, not to diagnose a medical condition.
No
The device is a physical glove, not software. The description clearly outlines its material (synthetic rubber), physical characteristics (flock-lined, beaded cuff), and manufacturing standards for a tangible product.
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 "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function for personal protection and infection control.
- Device Description: The description reinforces the intended use as a protective glove worn on the hand.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not interact with or analyze such specimens.
- Performance Studies: The performance studies focus on the physical properties, freedom from pinholes, powder residual, and biocompatibility of the glove, which are relevant to its function as a barrier and for user safety, not for diagnostic purposes.
Therefore, this device falls under the category of a medical device used for protection and infection control, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Powder-Free Nitrile Examination Glove Flock-Lined, Black Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Powder Free Nitrile Examination Gloves Flock-Lined, Black Color Non-Sterile, is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. The gloves are lined with cotton flock, ambidextrous with beaded cuff, black colored, single use disposable devices that comes is six sizes (XS, S, M, L, and XL) supplied in non-sterile state.
The gloves are made of synthetic rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical and performance characteristics meet all requirements of ASTM D6319-10. Powder was not used for this glove's manufacturing process.
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
"examiner's hand" - indicating medical professionals in a healthcare setting.
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 device performance was evaluated based on technological characteristics compared to ASTM or equivalent standards:
- Dimensions: Meets ASTM D6319-10
- Physical Properties (Before/After Aging): Meets ASTM D6319-10
- Freedom from pinholes: Meets ASTM D6319-10 / ASTM D5151-11
- Powder Residual: Meets
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2016
Shen Wei (USA), Inc. % Ms. Cheryl Bailey-Kroll Compliance Manager 33278 Central Ave. Suite 102 Union City, California 94587
Re: K161074
Trade/Device Name: Powder Free Nitrile Examination Gloves Flock-Lined, Black Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 12, 2016 Received: October 18, 2016
Dear Cheryl Bailey-Kroll,
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161074
Device Name
Powder-Free Nitrile Examination Glove Flock-Lined, Black Color
Indications for Use (Describe)
Powder-Free Nitrile Examination Glove Flock-Lined, Black Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is labeled "Attachment One" and features a logo for "Shen Wei usa inc." The logo includes a green hand graphic above the text. Below the company name is the tagline "PROMOTING YOUR SUCCESS!" in a smaller font size.
510(k) Summary
1.0 Submitter:
| Name: | Shen Wei USA Inc. |
|---|---|
| Address: | 33278 Central Ave. Suite 102 |
| Union City, CA. 94587 | |
| FDA Est Reg#: | 2939388 |
| Phone No: | 510-429-8692 |
| Fax No: | 510-487-5347 |
Manufacturer:
| Name:
Address: | ZHANGJIAGANG DAYU RUBBER PRODUCTS CO., LTD
XIZHANG TOWN
ZHANGJIAGANG CITY, CHINA 215614 |
|-------------------|-----------------------------------------------------------------------------------------------|
| FDA Est Reg#: | 1000254914 |
| Phone No: | 520-845-0023 |
| Fax No: | 520-845-0311 |
Date 510k Summary was prepared: October 10, 2016
2.0 Contact Person:
| Name: | Cheryl Reep |
|---|---|
| Phone No: | 510-429-8692 |
| Fax No: | 510-487-5347 |
| Email: | Creep@shenweiusa.com |
3.0 Name of the device:
| Trade Name: | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color |
|---|---|
| Device Name: | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color |
| Common Name: | Patient Examination Gloves |
| Classification Name: | Patient examination glove |
| Device Class: | Class 1 |
| Regulation Number: | 21 CFR 880.6250 |
| Product Code: | 80 LZA |
4.0 Predicate Device Information:
Device Name: Non Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating Company Name: Siam Sempermed Corp. Ltd. 510K Number: K070639
5.0 Description of the Device:
Powder Free Nitrile Examination Gloves Flock-Lined, Black Color Non-Sterile, is a disposable device intended for
4
medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. The gloves are lined with cotton flock, ambidextrous with beaded cuff, black colored, single use disposable devices that comes is six sizes (XS, S, M, L, and XL) supplied in non-sterile state.
The gloves are made of synthetic rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical and performance characteristics meet all requirements of ASTM D6319-10. Powder was not used for this glove's manufacturing process.
6.0 Labeling and Intended Use of the Device:
The Powder Free Nitrile Examination Gloves Flock-Lined, Black Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
7.0 Shelf Life or Expiration Data: Not Applicable
8.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile Examination Gloves Flock-Lined, Black Color is summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties | ||
| (Before/After Aging) | ASTM D6319-10 | Meets |
| Freedom from pinholes | ASTM D6319-10 / ASTM | |
| D5151-11 | Meets | |
| Powder Residual | ASTM D6319-10 | Meets |