(341 days)
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.
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.
This document is a 510(k) premarket notification for a medical device (Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of AI performance. Therefore, I cannot provide details on AI acceptance criteria, sample sizes for AI tests, expert qualifications, or MRMC studies.
However, I can extract the acceptance criteria and device performance for the glove itself, as per the submitted documentation.
1. Table of Acceptance Criteria and Reported Device Performance
| 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 (Primary Skin Irritation in Rabbits) | ISO 10993-10:2010 | Not a skin irritant under the conditions of study. |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10:2010 | Not a contact sensitizer under the conditions of the study. |
| Powder Residue | (Implied by standard and predicate) | Meets Standard Requirements < 2mg/glove |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test listed (e.g., how many gloves were tested for dimensions, pinholes, or physical properties). It refers to meeting the "Standard Requirements" of ASTM D6319-10 and ISO 10993-10. These standards would dictate the sample sizes and methodologies for testing.
The medical device manufacturers are listed as:
- ZHANGJIAGANG DAYU RUBBER PRODUCTS CO., LTD (ZHANGJIAGANG CITY, CHINA)
- ZHENJIANG SUHUI LATEX PRODUCTS CO.LTD. (ZHENJIANG CITY, CHINA)
- NINGXIA MARVISUN RUBBER & PLASTIC PRODUCTS CO., LTD. (YINCHUAN, NINGXIA, CHINA)
Therefore, the tests were presumably conducted in China. The data would be considered prospective as it relates to the testing of this specific device for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for the performance of these gloves is based on established engineering and biological standards (ASTM D6319-10, ISO 10993-10). The performance is assessed through laboratory testing, not expert consensus in the way an AI model's output might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically relevant for subjective assessments or when discrepancies arise between multiple human readers and are common in clinical trials or AI performance evaluations. The tests performed for this medical device are objective laboratory measurements against defined standards.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is used for evaluating the effectiveness of diagnostic devices, often involving human readers interpreting medical images or data, and comparing their performance with and without an AI assist. This document concerns the physical and biocompatibility testing of medical gloves.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. There is no AI algorithm being evaluated in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by objective measurements and quantitative results from laboratory tests against pre-defined, standardized acceptance criteria specified in documents like ASTM D6319-10 (for physical properties and dimensions) and ISO 10993-10 (for biocompatibility). For example, for "Freedom from pinholes," the ground truth is simply whether the glove passes the specified water leak test.
8. The sample size for the training set
This is not applicable. There is no AI model or training set involved in the evaluation of these medical gloves.
9. How the ground truth for the training set was established
This is not applicable as there is no training set mentioned in the document.
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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
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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
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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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510K# K162312 SUMMARY
1.0 Submitter:
| Name: | Shen Wei USA Inc. |
|---|---|
| Address: | 33278 Central Ave. Suite 102Union 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 TOWNZHANGJIAGANG 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/AfterAging) | 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 inRabbits | Not a skin irritant under the conditionsof study. |
| ii. Dermal Sensitization | Not a contact sensitizer under theconditions 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 ExamGloves with Aloe Vera, Green Color | Biodegradable Powder Free Nitrile ExamGloves with Aloe Vera, Green Color |
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| Device Description/Regulation Number | Patient examination glove / 21 CFR880.6250 | Patient examination glove / 21 CFR 880.6250 |
|---|---|---|
| Product Code | LZA | LZA |
| Intended use | Intended for medical purpose that isworn on the examiner's hand toprevent contamination betweenpatient and examiner. | Intended for medical purpose that is worn onthe examiner's hand to prevent contaminationbetween patient and examiner. This device issingle use only. |
| Instruction for Use | A disposable device intended formedical purpose that is worn on theexaminer's hand to preventcontamination between patient andexaminer. This device is not intendedto be used as a chemical barrier. | A disposable device intended for medicalpurpose that is worn on the examiner's handto prevent contamination between patient andexaminer. This device is single use only. |
| Materials | Nitrile | Nitrile |
| Color / Coating | Green / Aloe Vera | Green / Aloe Vera |
| Design | Ambidextrous in different sizes perASTM 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 < 2mg/glove | Meets Standard Requirements < 2mg/glove |
| Single Use | Yes | Yes |
| Biocompatibility Test | i Not a primary skin irritantii. Not a contact sensitizer | Not a primary skin irritant nor a contactsensitizer under the conditions of study. |
Summary of Difference and Comparison of Safety and Effectiveness- The subject device differs from the predicate in that:
- The subject device has biodegradation property within landfills tested per ASTM D5526-94 while the predicate device does not have same technological feature. The difference in biodegradation properties does not affect the subject device's safety and effectiveness; subject device met the requirements for Biocompatibility Testing and ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application. The difference in technological feature does not change the performance or affect the intended use of the device.
- . Biodegradability is not a medical claim and therefore was not reviewed by FDA.
- Summary of Clinical Testing: Not applicable. No clinical testing was performed. 10.0
- 11.0 Conclusion: The conclusion drawn from the non-clinical test demonstrate that the subject device, Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color, is as safe, as effective, and performs as well as the legally marketed device.
§ 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.