(88 days)
Not Found
No
The device is a simple vinyl glove and the summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device, a vinyl glove, is intended to prevent contamination and is used for medical purposes, but it does not treat or cure a disease or condition.
No
Explanation: The device is a vinyl glove intended to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device description clearly states it is a physical, disposable glove made of vinyl, intended to be worn on the hands. It undergoes physical testing according to ASTM standards, indicating it is a hardware device.
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 hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and standards related to gloves for medical examination. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is a medical glove intended for barrier protection during medical examinations.
N/A
Intended Use / Indications for Use
The Vinyl Glove is disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes
LYZ
Device Description
The subject device is powder free vinyl patient examination gloves. The subject device is clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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 tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards as shown in Table 5 Biocompatibility and Table 6 Non-Clinical Testing below:
Biocompatibility Testing:
- ISO 10993-10:2010 Tests For Irritation And Skin Sensitization: Purpose - To determine if device is a skin irritant. Acceptance Criteria - The device must be a non-irritant. Results - Pass.
- ISO 10993-10:2010 Tests For Irritation And Skin Sensitization: Purpose - To determine if device is a skin sensitizer. Acceptance Criteria - The device must be a non- sensitizer. Results - Pass.
- ISO 10993-5:2009 Tests For In Vitro Cytotoxicity: Purpose - To determine if the device is potential toxicity to L-929 cells. Acceptance Criteria - The device must be a non toxicity. Results - Pass.
Non-Clinical Testing:
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves: Purpose - To determine residual powder. Acceptance Criteria - =230; Width(mm): S: 85+-5; M: 95+-5; L: 105+-5; XL: 115+-5. Results - Length(mm):>230; Width(mm): S: 84-86; M: 95-97; L: 105-107; XL: 115-117; Pass.
- ASTM D412-06a-2013 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension: Purpose - To determine physical properties. Acceptance Criteria - Thickness (mm): Finger: >=0.08, Palm: >=0.08; Before Aging: Tensile Strength>=11MPa, Ultimate Elongation>=300%; After Aging: Tensile Strength>=11MPa, Ultimate Elongation>=300%. Results - Finger: 0.09-0.11, Palm: 0.08-0.11; Before Aging: Tensile Strength: 15.1~17.4 MPa, Ultimate Elongation: 552%
560%; After Aging: Tensile Strength: 15.717.4 MPa, Ultimate Elongation: 527%~550%; Pass.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
September 17, 2021
Jiangsu Dihong Industry and Trade Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K211904
Trade/Device Name: Vinyl Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: April 19, 2021 Received: June 21, 2021
Dear Boyle Wang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
542 of the Act); 21 CFR 1000-1050.
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Liqun Zhao -S
For Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211904
Device Name Vinyl Glove
Indications for Use (Describe)
The Vinyl Glove is disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary- K211904
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Jiangsu Dihong Industry and Trade Co.,Ltd. Name: Address: Donqxiaodian Industrial Park, Shuyang City, Jiangsu, China Phone Number: +86-18761104047 Contact: Sue Chen Date of Preparation: 09/09/2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Vinyl Glove Common name: Vinyl Patient Examination Glove Classification name: Non-powdered Patient Examination Glove Model(s): S, M, L, XL
3.0 Classification
Production code: LYZ Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Hebei Hongtai Plastic Products Company Limited Vinyl Patient Examination Gloves (White, Blue, Yellow) Device: 510(k) number: K163168
5.0 Indication for Use
4
The Vinyl Glove is disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
6.0 Device Description
The subject device is powder free vinyl patient examination gloves. The subject device is clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject device | Predicate device | Comparison |
|---|---|---|---|
| 510(k) number | K211904 | K163168 | - |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Vinyl Glove is disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | The Vinyl Examination Glove (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | Same |
| Powdered or | |||
| Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Labeling | |||
| Information | Single use, powder free, device color, device name, glove size and quantity, Vinyl Glove, Non-Sterile | Single use, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Similar |
Table1-General Comparison
Table2 Device Dimensions Comparison
| Predicate
Device
| (K163168) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Length, mm | XS | S | M | L | XL | ||
| 230 | 230 | 235 | 245 | 245 | min | ||
| Width, mm | 80 | 85 | 95 | 105 | 115 | $\pm 5$ | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.08 | min | |||||
| Subject Device | Designation | Size | Tolerance |
5
| (K211904) | S | M | L | XL | ||
|---|---|---|---|---|---|---|
| Length, mm | 230 | 230 | 230 | 230 | min | |
| Width, mm | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | ||||||
| Finger | 0.08 | min | ||||
| Palm | 0.08 | min | ||||
| Remark | Similar |
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250,so the differences do not raise any new safety or performance questions.
| Item | Subject device
(K211904) | Predicate device
(K163168) | Comparison | |
|------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|------------|------------|
| Colorant | Clear | White, Blue, Yellow | Analysis 1 | |
| Physical
Properties | Before Aging
Tensile Strength | 11MPa, min | 15MPa, min | Analysis 2 |
| | Ultimate Elongation | 300%min | 380%min | Analysis 2 |
| | After Aging
Tensile Strength | 11MPa, min | 15MPa, min | Analysis 2 |
| | Ultimate Elongation | 300%min | 380%min | Analysis 2 |
| Comply with ASTM D5250 | Comply with ASTM D5250 | Comply with ASTM D5250 | Same | |
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Same | |
| Powder Content | 230 |
| | | Width(mm): | Width(mm): |
| | | S: 85±5; | S: 84-86 |
| | | M: 95±5; | M: 95-97 |
| | | L: 105±5; | L: 105-107 |
| | | XL: 115±5; | XL: 115-117 |
| | | | Pass |
| ASTM D412-06a-2013
Standard Test Methods
for Vulcanized Rubber
and Thermoplastic
Elastomers—Tension | To determine physical
properties | Thickness (mm): | Finger: 0.09-0.11 |
| | | Finger: ≥0.08 | Palm: 0.08-0.11 |
| | | Palm: ≥0.08 | Pass |
| | | Before Aging: | Before Aging: |
| | | Tensile
Strength≥11MPa | Tensile Strength:
15.1~17.4 MPa |
| | | Ultimate
Elongation≥300% | Ultimate Elongation:
552%560% |17.4 MPa |
| | | After Aging: | After Aging: |
| | | Tensile
Strength≥11MPa | Tensile Strength:
15.7
| | | Ultimate
Elongation≥300% | Ultimate Elongation:
527%~550% |
| | | | Pass |
9.0 Summary of Clinical Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device in 510(k) submission K211904, Vinyl Glove, is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K163168.