(143 days)
Not Found
No
The device is a standard medical glove and the summary contains no mention of AI or ML.
No
The device is described as a disposable glove for preventing contamination, not for treating a disease or condition.
No
The device, Vinyl Examination Gloves, is described as a disposable device worn on an examiner's hands to prevent contamination. Its intended use is not for diagnosing medical conditions, but rather as a barrier for hygiene and protection.
No
The device is a physical product (gloves) and the description focuses on material properties and physical performance, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Intended Use: The intended use of these gloves is to be worn on the examiner's hands to prevent contamination between the patient and the examiner. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and standards related to the glove's material and performance as a barrier.
- Performance Studies and Metrics: The performance studies and key metrics are all related to the physical integrity, safety (biocompatibility), and barrier properties of the gloves (watertightness, tensile strength, etc.). There are no metrics related to analyzing biological specimens or providing diagnostic information.
The device is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vinyl Examination Gloves(Yellow) are disposable device intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
The subject device is powder free vinyl patient examination gloves. The subject device is yellow. 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 / Not Found
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:
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTMD5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250-19. The tensile strength and ultimate elongation are different with that of the predicate, but they all meet the requirements of ASTM D5250.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Length(mm):≥230; Results: > 230/ Pass
- Width(mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5; Results: S: 84-85/Pass M: 94-96/Pass L: 104-106/Pass XL: 113-115/Pass
- Thickness (mm): Finger: ≥0.08 Palm: ≥0.08; Results: Finger: 0.12~0.13/Pass Palm: 0.08/Pass
- Watertightness Test for Detection of Holes: Meet the requirements of ASTM D5151 AQL 2.5; Results: 0/125 leaks / Pass
- Powder Content (Medium glove is the representative sample of the product): Meet the requirements of ASTM D6124
§ 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/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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
October 24, 2021
Liuping Trading CO.,LTD. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai. 200120 China
Re: K211698
Trade/Device Name: Vinyl Examination Gloves(Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: September 17, 2021 Received: September 23, 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.
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
1
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 531-542 of the Act); 21 CFR 1000-1050.
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,
For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211698
Device Name Vinyl Examination Gloves(Yellow)
Indications for Use (Describe)
The Vinyl Examination Gloves(Yellow) are disposable device intended for medical purposes that are 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
(K211698)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: LIUPING TRADING CO.,LTD. Address: Xingtong Town, Linyi County, Dezhou City 251500, Shandong, China. Phone Number: Contact: Jing Li Date of Preparation: 09/17/2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Vinyl Examination Gloves (Yellow) 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 Device: Vinyl Patient Examination Gloves (White, Blue, Yellow) 510(k) number: K163168
5.0 Indication for Use
4
The Vinyl Examination Gloves(Yellow) is a 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 yellow. 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 Characteristics Comparison Table With The Predicate Device
| Item | Subject device | Predicate device | Comparison |
|---|---|---|---|
| 510(k) number | K211698 | K163168 | / |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Vinyl Examination Gloves (Yellow) is a 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 Examination Gloves, 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 | ||||||
| 230 | S | ||||||
| 230 | M | ||||||
| 235 | L | ||||||
| 245 | XL | ||||||
| 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
| (K211698) | 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 D5250-19.
| Item | | Subject device
K211698 | Predicate device
K163168 | Comparison | |
|------------------------|------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------|
| Colorant | | Yellow | White, Blue, Yellow | Same | |
| Physical
Properties | Before
Aging | Tensile
Strength
11MPa, min | 15MPa, min | Different | |
| | | Ultimate
Elongation
300%min | 380%min | Different | |
| | After
Aging | Tensile
Strength
11MPa, min | 15MPa, min | Different | |
| | | Ultimate
Elongation
300%min | 380%min | Different | |
| | 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 | | Meet the
requirements of
ASTM D6124 230/ Pass |
| | | Width(mm):
S: 85±5;
M: 95±5;
L: 105±5;
XL: 115±5;
Thickness (mm):
Finger: ≥0.08
Palm: ≥0.08 | Width:
S: 84-85/Pass
M: 94-96/Pass
L: 104-106/Pass
XL: 113-115/Pass
Finger: 0.12~0.13/Pass
Palm: 0.08/Pass |
| ASTM D5151 | Watertightness
Test for
Detection of
Holes | Meet the requirements of ASTM D5151
AQL 2.5 | 0/125 leaks / Pass |
7
| ASTM D6124 | Powder
Content
(Medium glove
is the
representative
sample of the
product) | Meet the requirements of ASTM D6124