(341 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML technology.
No
The device is an exam glove intended to prevent contamination between patient and examiner, not to provide therapeutic treatment.
No
The device is described as "a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This function is protective and preventative, not diagnostic.
No
The device is a physical product (gloves) and the description focuses on material properties, manufacturing processes, and physical performance characteristics, 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 is clearly stated as a disposable device worn on the examiner's hand to prevent contamination between patient and examiner. This is a barrier device for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics, materials, and manufacturing process of the glove. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment based on the analysis of specimens.
The device is a medical device, specifically an examination glove, but it falls under the category of personal protective equipment and barrier devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green 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
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green 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 coated with Aloe Vera, ambidextrous with beaded cuff, green colored, single use disposable devices that comes in six sizes (XS, S, M, L, XL and XXL) supplied in non-sterile state. The qloves are powder free and are manufactured using online chlorination process to avoid sticky surface and obtain good donning properties.
The gloves are made of Nitrile Butadiene Rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Its physical and performance characteristics meet all requirements of ASTM D6319-10.
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
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 testing was performed to compare the subject device to ASTM or equivalent standards for dimensions, physical properties (Before/After Aging), freedom from pinholes, and biocompatibility.
Key results:
- Dimensions: Meets Standard Requirements
- Physical Properties (Before/After Aging): Meets Standard Requirements
- Freedom from pinholes: Meets Standard Requirements
- Biocompatibility (ISO 10993-10:2010): Primary Skin Irritation in Rabbits - Not a skin irritant under the conditions of study. Dermal Sensitization - Not a contact sensitizer under the conditions of the study.
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.
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Image /page/0/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" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2017
Shen Wei USA Inc. Cheryl Bailey-Kroll Compliance Manager 33278 Central Ave Ste 102 Union City, California 94587
Re: K162312
Trade/Device Name: Biodegradable Powder Free Nitrile Exam Gloves With Aloe Vera. Green Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: July 20, 2017 Received: July 21, 2017
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 device
1
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tara A. Ryan -S
for Lori Wiggins, MPT, CLT Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K162312
Device Name
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
Indications for Use (Describe)
The Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green 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 shows a logo for Shen Wei USA Inc. The logo features a green hand above the company name, with the words "Shen Wei" in a larger, bolder font than "usa inc." Below the company name, there is a colorful line with the words "PROMOTING YOUR SUCCESS!" in red.
510K# K162312 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 |
| Manufacturers: | |
| Name: | ZHANGJIAGANG DAYU RUBBER PRODUCTS CO., LTD |
| Address: | XIZHANG TOWN |
| ZHANGJIAGANG CITY, CHINA 215614 | |
| FDA Est Reg#: | 1000254914 |
| Phone No: | 520-845-0023 |
| Fax No: | 520-845-0311 |
| Name: | ZHENJIANG SUHUI LATEX PRODUCTS CO.LTD. |
| Address: | LIANHE CHUN, YANGZHONG CITY, JIANGSU 212212, CHINA |
| FDA Est Reg#: | 9615498 |
| Name: | NINGXIA MARVISUN RUBBER & PLASTIC PRODUCTS CO., LTD. |
| Address: | WORKSHOP UNIT 21 & 27, MID. & SML. SZ. ENT. DEVELOPMENT PARK, NINGXIA HIGH TECH DEVELOPMENT ZONE YINCHUAN, NINGXIA, Area II, CHINA |
| FDA Est Reg#: | 3008932202 |
Date 510k Summary was prepared 07/20/17
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: | Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color |
|---|---|
| Device Name: | Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color |
| Common Name: | Patient Examination Gloves |
| Classification Name: | Patient examination glove |
| Device Class: | Class I |
| Regulation Number: | 21 CFR 880.6250 |
| Product Code: | LZA |
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4.0 Predicate Device Information:
The predicate device is K993876, POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA GREEN, approved on 2/7/2000. Class I Powder Free Nitrile Examination gloves, 80LZA, which meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20.
5.0 Description of the Device:
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green 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 coated with Aloe Vera, ambidextrous with beaded cuff, green colored, single use disposable devices that comes in six sizes (XS, S, M, L, XL and XXL) supplied in non-sterile state. The qloves are powder free and are manufactured using online chlorination process to avoid sticky surface and obtain good donning properties.
The gloves are made of Nitrile Butadiene Rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Its physical and performance characteristics meet all requirements of ASTM D6319-10.
6.0 Intended Use of the Device:
The Biodegradable Powder Free Nith Aloe Vera, Green 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: Glove's shelf life is 3 years.
8.0 Summary of the Technological Characteristics of the Device:
The Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meets Standard Requirements |
| Physical Properties (Before/After | ||
| Aging) | ASTM D6319-10 | Meets Standard Requirements |
| Freedom from pinholes | ASTM D6319-10 / ASTM D5151- | |
| 11 | Meets Standard Requirements | |
| Biocompatibility | ISO 10993-10:2010: | |
| i. Primary Skin Irritation in | ||
| Rabbits | Not a skin irritant under the conditions | |
| of study. | ||
| ii. Dermal Sensitization | Not a contact sensitizer under the | |
| conditions of the study. |
Discussion of Similarities and Differences 9.0
The table below shows similarities and differences between the proposed new device.
| Characteristics | Predicate Device | Proposed New Device |
|---|---|---|
| Name | K993876, Powder Free Nitrile Exam | |
| Gloves with Aloe Vera, Green Color | Biodegradable Powder Free Nitrile Exam | |
| Gloves with Aloe Vera, Green Color |
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| Device Description/
Regulation Number | Patient examination glove / 21 CFR
880.6250 | Patient examination glove / 21 CFR 880.6250 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA | LZA |
| Intended use | Intended for medical purpose that is
worn on the examiner's hand to
prevent contamination between
patient and examiner. | 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. |
| Instruction for Use | 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 not intended
to be used as a chemical barrier. | 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. |
| Materials | Nitrile | Nitrile |
| Color / Coating | Green / Aloe Vera | Green / Aloe Vera |
| Design | Ambidextrous in different sizes per
ASTM 6319-00 dimensions'
requirement | SAME |
| Biodegradation Properties | None | Biodegradable, Difference |
| Performance: | | |
| I. Freedom from Holes | Meets ASTM D6319-00 | Meets Standard Requirements |
| II. Dimension | Meets ASTM D6319-00 | Meets Standard Requirements |
| III. Physical Properties | Meets ASTM D6319-00 | Meets Standard Requirements |
| IV. Powder Residue | Meets