(87 days)
Not Found
No
The device is a patient examination glove, a simple barrier device. The description and performance studies focus on physical and biological properties, with no mention of AI or ML.
No
The device is described as a disposable patient examination glove intended to prevent contamination, not to treat or alleviate a medical condition.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to diagnose a medical condition.
No
The device description clearly states it is a physical product (patient examination gloves) and the performance studies focus on physical and biological properties, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Description and Intended Use: The provided information clearly states that the device is a "patient examination glove" intended to be "worn upon the examiner's hands or fingers to prevent contamination between patient and examiner." This is a barrier device used for protection and hygiene during physical examinations.
- Lack of Diagnostic Function: There is no mention of the glove being used to analyze samples, detect biomarkers, or provide any diagnostic information about the patient's health. Its function is purely protective.
The information provided describes a Class I medical device (likely exempt from premarket notification) used for infection control, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers 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 synthetic patient examination gloves. The subject device is blue. 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 or fingers
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:
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
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
Key results:
ASTM D5250 - Physical Dimensions Test:
Length(mm): >= 230/ Pass
Width(mm): XS: 78-79/ Pass; S: 87-88/Pass; M: 95-98/Pass; L: 103-107/Pass; XL: 116-117/Pass
Thickness (mm): Finger: 0.08-0.09/Pass; Palm: 0.10/Pass
ASTM D5151 - Watertightness Test for Detection of Holes: 0/125 leaks / Pass
ASTM D6124 - Powder Content: 0.12 mg/Pass
ASTM D412 - Physical properties:
Before Aging:
Tensile Strength: 13-17/Pass
Ultimate Elongation: 370-495/Pass
After Aging:
Tensile Strength: 12-16/Pass
Ultimate Elongation: 370-445/Pass
ISO 10993-5 - Cytotoxicity: Under conditions of the study, did not show potential toxicity to L-929 cells./ Pass
ISO 10993-10 - Irritation: Under the conditions of the study, not an irritant/ Pass
ISO 10993-10 - Sensitization: Under 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. Food & Drug Administration" in blue text.
September 23, 2021
Yunnan Huazhiyuan Medical Technology Co., Ltd. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
Re: K212002
Trade/Device Name: Synthetic Vinyl Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: June 21, 2021 Received: June 28, 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
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 531-542 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,
Liqun Zha
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212002
Device Name Synthetic Vinyl Examination Gloves
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers 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 (K212002)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Yunnan Huazhiyuan Medical Technology Co., Ltd. Address: Yangjie Industrial Park,Jianshui County,Honghe Hani and Yi Autonomous Prefecture, Yunnan Province, 654300 China Phone Number: +86-18252909158 Fax Number: +86-873-7921166 Contact: Yun Gao Date of Preparation: Aug.31,2021
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: Synthetic Vinyl Examination Gloves Common name: Vinyl Patient Examination Glove Classification name: Non-powdered Patient Examination Glove Model(s): XS、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: Zibo Huiying Medical Products, Co. Ltd. Trade/Device Name: Synthetic Patient Examination Vinyl Gloves,Powder
4
Free,Blue
510(k) number: K153028
5.0 Indication for Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
6.0 Device Description
The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. 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
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject device | Predicate device | Comparison |
| 510(k) number | K212002 | K153028 | Different |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | A patient examination glove | ||
| is a disposable device | |||
| intended for medical | |||
| purposes that is worn upon | |||
| the examiner's hands or | |||
| fingers to prevent | |||
| contamination between | |||
| patient and examiner. | A patient examination glove | ||
| is a disposable device | |||
| intended for medical | |||
| purposes that is worn upon | |||
| the examiner's hands or | |||
| fingers 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, | |||
| product name. Non-Sterile | Single use, powder free, | ||
| device color, device name, | |||
| glove size and quantity, | |||
| product name. Non-Sterile | Similar |
Table1-General Comparison
Table2 Device Dimensions Comparison
| Predicate
| Device(K153028) | Designation | Size | Tolerance |
|---|---|---|---|
| Length, mm | Average over 234 on M size | - | |
| Width, mm | Average over 96 on M size | - |
5
| Thickness, mm: | |||||||
|---|---|---|---|---|---|---|---|
| Finger | Average 0.096 | - | |||||
| Palm | Average 0.098 | - | |||||
| Subject Device | |||||||
| (K212002) | Designation | Size | Tolerance | ||||
| XS | S | M | L | XL | |||
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 75 | 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 | Predicate device | Comparison | |
|---|---|---|---|---|
| Colorant | Blue | Blue | Same | |
| Physical | ||||
| Properties | Before Aging | |||
| Tensile Strength | 11MPa, min | Average 16.9MPa | Different | |
| Ultimate | ||||
| Elongation | 300%min | Average 550% | Different | |
| After Aging | ||||
| Tensile Strength | 11MPa, min | Average 14.4MPa, min | Different | |
| Ultimate | ||||
| Elongation | 300%min | Average 550% | 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 | 0.12 mg per glove. Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Similar |
| Table3 Performance Comparison | |
|---|---|
Analysis: The tensile strength and ultimate elongation 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.
Table4 Safety Comparison
6
| Item | Subject device | Predicate device | Comparison | |
|---|---|---|---|---|
| Material | Poly Vinyl Chloride | |||
| Polyurethane | ||||
| Nitrile | ||||
| Di-(2-ethylhexyl) | ||||
| Terephthalate(DOTP) | Poly Vinyl Chloride | |||
| Polyurethane | ||||
| Diisononyl | ||||
| Phthalate | ||||
| (DINP) | Similar | |||
| Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | Same |
| Sensitization | Under conditions of the study, not a sensitizer. | |||
| Cytotoxicity | Under conditions of the study, did not show potential toxicity to L-929 cells. | Not provided | Different | |
| Label and Labeling | Meet FDA's | |||
| Requirement | Meet FDA's Requirement | Same |
Analysis: The materials of the subject device are little different with that of the predicate, but they all meet the performance requirements of ASTM D5250, also biocompatibility test has been performed on subject device and the test result can meet the requirements of ISO 10993 standards. Therefore, the differences will not raise any safety and effectiveness issues.
8.0 Discussion of Non-clinical Testing
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
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
| Test | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ------ | --------- | --------------------- | --------- |
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| Methodology | |||||
|---|---|---|---|---|---|
| ASTM D5250 | Physical | ||||
| Dimensions | |||||
| Test | Length(mm): $\geq$ 230; | Length: $\geq$ 230/ Pass | |||
| Width(mm): | Width: | ||||
| XS:75±5; | XS: 78-79/ Pass | ||||
| S: 85±5; | S: 87-88/Pass | ||||
| M: 95±5; | M: 95-98/Pass | ||||
| L: 105±5; | L: 103-107/Pass | ||||
| XL: 115±5; | XL: 116-117/Pass | ||||
| Thickness (mm): | |||||
| Finger: $\geq$ 0.08 | Finger: 0.08-0.09/Pass | ||||
| Palm: $\geq$ 0.08 | Palm: 0.10/Pass | ||||
| ASTM D5151 | Watertightness | ||||
| Test for | |||||
| Detection of | |||||
| Holes | Meet the requirements of ASTM D5151 | ||||
| AQL 2.5 | 0/125 leaks / Pass | ||||
| ASTM D6124 | Powder | ||||
| Content | |||||
| (Medium glove | |||||
| is the | |||||
| representative | |||||
| sample of the | |||||
| product) | Meet the requirements of ASTM D6124 | ||||
| $ |