(99 days)
Not Found
No
The device is a patient examination glove, and the description focuses on material properties and standard compliance, with no mention of AI or ML.
No
The device, patient examination gloves, prevents contamination and does not treat or cure a disease or medical condition.
No
The device is a patient examination glove, which is a barrier device used to prevent contamination. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a physical product (patient examination gloves) and the performance studies are related to physical properties and biocompatibility, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "worn upon the examiner's hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical characteristics and standards related to gloves (material, color, standards for physical properties, watertightness, etc.). There is no mention of analyzing samples from the body (blood, urine, tissue, etc.) or providing information about a patient's health status.
- Lack of Diagnostic Elements: There are no mentions of image processing, AI/ML, input imaging modality, or performance metrics typically associated with diagnostic devices (sensitivity, specificity, AUC, etc.).
- Performance Studies: The performance studies focus on the physical and biological safety of the glove itself (watertightness, tensile strength, cytotoxicity, irritation, sensitization), not on the accuracy of a diagnostic result.
In summary, this device is a medical device intended for barrier protection, not for diagnosing a disease or condition.
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 to prevent contamination between patient and examiner.
Product codes
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / medical purposes
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 based on the following standards:
ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
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.
Biocompatibility evaluation was performed based on the following standards:
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Key results from non-clinical testing (Table 5):
- Physical Dimensions Test (ASTM D5250):
- Length: >230 mm (Acceptance Criteria: >=230 mm) - Pass
- Width: S: 88-90, M: 95-97, L: 106-108, XL: 113-116 (Acceptance Criteria: S: 85 +/- 5; M: 95 +/- 5; L: 105 +/- 5; XL: 115 +/- 5) - Pass
- Thickness: Finger: 0.08-0.10 mm, Palm: 0.09 mm (Acceptance Criteria: Finger: >=0.08 mm; Palm: >=0.08 mm) - Pass
- Watertightness Test for Detection of Holes (ASTM D5151): 0/125 leaks (Acceptance Criteria: Meet the requirements of ASTM D5151 AQL 2.5) - Pass
- Powder Content (ASTM D6124): 0.11 mg (Acceptance Criteria: 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 24, 2021
Tangshan Hongyun Plastic Products Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K211516
Trade/Device Name: Disposable Vinyl Nitrile Synthetic Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: May 13, 2021 Received: May 17, 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
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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 medical devices and radiation-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,
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211516
Device Name
Disposable Vinyl Nitrile Synthetic Gloves Powder Free
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon 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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510(k) Summary (K211516)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Tangshan Hongyun Plastic Products Co., Ltd. Name: Address: South Shenggezhuang Village,Pachigang Town, Luannan,Tangshan, Hebei 063500, China. Phone Number: +86-13933365259 Contact: Suying Le Date of Preparation: 08/11/2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Disposable Vinyl Nitrile Synthetic Gloves Powder Free 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: Zibo Huiying Medical Products, Co. Ltd. Device: Synmax Synthetic Patient Examination Vinyl Gloves,Powder Free,Blue 510(k) number: K153028
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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 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
| Item | Subject device | Predicate device | Comparison |
|---|---|---|---|
| 510(k) number | K211516 | K153028 | / |
| 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 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 | - |
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| Width, mm | Average over 96 on M size | |||||
|---|---|---|---|---|---|---|
| Thickness, mm: | ||||||
| Finger | Average 0.98 | - | ||||
| Palm | Average 0.096 | - | ||||
| Subject Device | ||||||
| (K211516) | Designation | Size | Tolerance | |||
| 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.
| 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 500% | Different | ||
| 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 | 0.11 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.
Table4 Safety Comparison
| Item | Subject device | Predicate device | Comparison |
|---|---|---|---|
| Material | Poly Vinyl Chloride | ||
| Polyurethane | Poly Vinyl Chloride | ||
| Polyurethane | Similar |
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| Biocompatibility | Irritation | |||
|---|---|---|---|---|
| Nitrile | ||||
| Di-(2-ethylhexyl) | ||||
| Terephthalate(DOTP) | Diisononyl Phthalate | |||
| (DINP) | ||||
| 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. | / | Similar | ||
| 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.
8.0 Summary of Non-clinical Testing
The subject device were evaluated according to the following standards:
ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
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.
Biocompatibility Testing:
The biocompatibility evaluation for the subject device were evaluated
according to the following standard:
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Biocompatibility testing including cytotoxicity test, sensitization test and irritation test according to ISO 10993-1 standards, have been conducted on the Disposable Vinyl Nitrile Synthetic Gloves Powder Free. Under the parameters
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of the tests it is concluded that they are biocompatible, and that there are no new issues of biocompatibility regarding their use as intended.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length(mm):≥230; | Length: >230 |
| Width(mm): | Width: | ||
| S: 85±5; M: 95±5; L: 105±5; XL: 115±5 | S: 88-90 | ||
| M: 95-97 | |||
| L: 106-108 | |||
| XL: 113-116 | |||
| Pass | |||
| Thickness (mm) : | Finger: 0.08-0.10 | ||
| Finger: ≥0.08 | |||
| Palm: ≥0.08 | Palm: 0.09 | ||
| 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 | Meet the requirements of ASTM D6124 |