(97 days)
Not Found
No
The device is a disposable examination glove, and the description and performance studies focus on material properties and physical characteristics, with no mention of AI or ML.
No
The device, Vinyl compound examination gloves, is intended to prevent contamination between patient and examiner and does not directly treat or diagnose a disease or condition.
No
The device, vinyl examination gloves, is intended to prevent contamination between patient and examiner, not to diagnose medical conditions.
No
The device is a physical product (gloves) made of vinyl chloride, not software. The description focuses on material properties and physical standards.
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 describes a barrier device used for protection during physical examination, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics and materials of the glove, not on any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
IVDs are devices used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not perform any such tests.
N/A
Intended Use / Indications for Use
The Vinyl compound examination gloves is a disposable device intended for medical purposes that is 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 proposed device, Vinyl compound examination gloves are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is Blue. The design of proposed device is addressing the standards as ASTM D6124. ASTM D5151, and ASTM D5250.
The proposed device is not provided as sterilized
The proposed device is made of vinyl chloride.
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's hands to prevent contamination between patient and 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)
Bench tests were conducted to demonstrate that the proposed device complies with the following standards:
ASTM D5250-19 Standard Specification for Poly (vinyl chloride) Gloves for Medical Application. ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. ASTM D6124-17, Standard Test Method for Residual Powder on Medical Gloves. 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.
Performance Test Results Summary:
- ASTM D5151 (Testing for Freedom from holes):
- Acceptance Criteria: Freedom from holes
- Results: No water leakage is inspected form 200 samples
- ASTM D6124 (Determine the powder residue for powder free gloves):
- Acceptance Criteria:
§ 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 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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
July 29, 2021
Hebei Titans Hongsen Medical Technology Co., LTD. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building 15, XiYueHui, No. 5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K211229
Trade/Device Name: Vinyl compound examination gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: July 13, 2021 Received: July 19, 2021
Dear Ray 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.
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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.
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
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Indications for Use
510(k) Number (if known)
Device Name
Vinyl compound examination gloves
Indications for Use (Describe)
The Vinyl compound examination gloves is a 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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510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K211229
-
- Date of Preparation: 07/28/2021
-
- Sponsor
HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD.
Eastern Industrial Zone, NANGONG, HEBEI, 051800, CHINA Contact Person: Feng Shuangyan Position: Quality Management Representative Tel: +86-13733285059 Email: STQAFSY@126.COM
-
- Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang(@believe-med.com
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- Proposed Device Identification
Trade Name: Vinyl compound examination gloves Common Name: Vinyl Patient Examination Gloves (Powder Free)
- Proposed Device Identification
Regulatory Information: Classification: I Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
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Indication For Use Statement:
The Vinyl compound examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
-
- Predicate Device Identification
510(k) Number: K182043
- Predicate Device Identification
Product Name: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-colored) Manufacturer: HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD
6. Device Description
The proposed device, Vinyl compound examination gloves are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is Blue. The design of proposed device is addressing the standards as ASTM D6124. ASTM D5151, and ASTM D5250.
The proposed device is not provided as sterilized
The proposed device is made of vinyl chloride.
| 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 |
Table 1 Device Size Specifications
Table 2 Performance and Physical Specifications
| Before Aging | After Aging | Pinhole AQL | ||
|---|---|---|---|---|
| Tensile | ||||
| Strength | Ultimate | |||
| Elongation | Tensile | |||
| Strength | Ultimate | |||
| Elongation | ||||
| 11 MPa, min | 300 % min | 11 MPa, min | 300 % min | 4.0 |
The above data of size, performance, and physical specifications of proposed gloves meet all the
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current specifications listed in the ASTM standard D5250.
7. Comparison of Technological Characteristics
| ITEM | Proposed Device | Predicate Device (K182043) | Remark |
|---|---|---|---|
| Vinyl compound examination gloves | |||
| (K211229) | Single-use medical poly (vinyl chloride) | ||
| examination glove (Clear, Non-colored) | |||
| Product Code | LYZ | LYZ | SAME |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
| Intended Use | The Vinyl compound examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | The Single-use medical poly (vinyl chloride) examination glove (Clear, Non-colored) 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 |
| Table 1 General Comparison | |
|---|---|
| Table 2 Device Dimensions Comparison | |||||
|---|---|---|---|---|---|
| -------------------------------------- | -- | -- | -- | -- | -- |
| Designation | Size | Tolerance | |||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | |||
| Proposed Device (K211229) | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| Width, mm | 75 | 85 | 95 | 105 | 115 | $\pm$ 5 | |
| Thickness, mm: | |||||||
| Finger | 0.08 | min | |||||
| Palm | 0.08 | min | |||||
| Designation | Size | ||||||
| XS | S | M | L | XL | |||
| Predicate Device ((K182043) | Length, mm | 240 | 240 | 240 | 240 | 240 | min |
| Width, mm | 80 | 85 | 95 | 105 | 115 | $\pm$ 5 | |
| Thickness, mm: | |||||||
| Finger | 0.07 | min | |||||
| Palm | 0.08 | min | |||||
| Remark | Analysis 1 |
Analysis 1:
The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D 5250.
So we consider this as the proposed device is as safe, as effective, and performs as well as the predicate
6
device.
| ITEM | Proposed Device
Vinyl compound examination gloves
(K211229) | | Predicate Device (K182043)
Single-use medical poly (vinyl
chloride) examination glove (Clear,
Non-colored) | Remark | |
|------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------|-----------|
| Colorant | Blue | | Clear, Non-colored | Analysis 2 | |
| Physical
Properties | Before
Aging | Tensile
Strength | 11 MPa, min | 15 MPa, min | Analysis3 |
| | | Ultimate
Elongation | 300 % min | 350 % min | |
| | After
Aging | Tensile
Strength | 11 MPa, min | 15 MPa, min | SAME |
| | | Ultimate
Elongation | 300 % min | 350 % min | |
| Freedom from Holes | | Be free from holes when tested in
accordance with ASTM D5151 | | | |
| Powder Content | | Less than 2 mg per glove when tested
in accordance with ASTM D6124 | | | |
| Table 3 Performance Comparison | ||
|---|---|---|
Analysis 2:
The proposed device has different color to the predicate device, this different may causes potential biocompatibility risk, for this risk we conducted the biocompatibility test according to the ISO 10993-5 and ISO 10993-10, the test results showed that the proposed devices with blue colorant did not raise biocompatibility risk.
So we consider this as the proposed device is as safe, as effective, and performs as well as the predicate device.
Analysis 3:
The proposed device has different Tensile Strength before aging specification to the predicate device, but all proposed device meets the specification requirements of ASTM D 5250.
So we consider this as the proposed device is as safe, as effective, and performs as well as the predicate device.
| ITEM | Proposed Device | Predicate Device (K182043) | Remark |
|---|---|---|---|
| Vinyl compound examination | |||
| gloves (K211229) | Single-use medical poly (vinyl | ||
| chloride) examination glove (Clear, | |||
| Non-colored) |
Table 4 Safety Comparison
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| Material | Vinyl chloride | Vinyl chloride | SAME | |
|---|---|---|---|---|
| Biocompatibility | Cytotoxicity | Under conditions of the study, not a cytotoxicity. | Under conditions of the study, not a cytotoxicity. | SAME |
| Irritation | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant | SAME | |
| Sensitization | Under conditions of the study, not a sensitizer. | Under conditions of the study, not a sensitizer. | SAME |
Summary of Non-Clinical Tests 8.
Bench tests were conducted to demonstrate that the proposed device complies with the following standards:
ASTM D5250-19 Standard Specification for Poly (vinyl chloride) Gloves for Medical Application. ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. ASTM D6124-17, Standard Test Method for Residual Powder on Medical Gloves. 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.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D5151 | Testing for Freedom from holes | Freedom from holes | No water leakage is inspected form 200 samples |
| ASTM D6124 | Determine the powder residue for powder free gloves |