(47 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of examination gloves, with no mention of AI or ML.
No
The device, a disposable vinyl examination glove, is intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition in a patient.
No
Explanation: A diagnostic device is used to identify a disease, condition, or state. This device, a disposable examination glove, is intended to prevent contamination and is not used for diagnosis.
No
The device is a physical examination glove, not a software application. The description focuses on material properties and physical tests.
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 (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Description: The description clearly states the device is a "disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier device used for protection during physical examination.
- Lack of IVD Characteristics: The description does not mention any testing of samples, analysis of biological materials, or diagnostic purposes related to analyzing substances from the body.
The device described is a standard medical examination glove, which falls under the category of personal protective equipment (PPE) used in a medical setting.
N/A
Intended Use / Indications for Use
The DISPOSABLE VINYL EXAMINATION GLOVE (Pink, Black, Blue) 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 subject device is powder free vinyl examination glove. The subject device's color is pink, black and blue. It can be available in four specifications: S, M, L and XL. 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 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 10993-5 Third edition 2009-06-01, 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.
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:
Physical Dimensions Test (ASTM D5250): Length: > 230/Pass; Width: S: 83-87 / Pass, M: 92-97/ Pass, L: 104-106/ Pass, XL: 112-117/ Pass; Thickness: Finger:0.13-0.14/ Pass, Palm:0.09-0.11/Pass
Watertightness Test for Detection of Holes (ASTM D5151): 0/125 / Pass
Powder Content (ASTM D6124): 0.170.26mg / Pass22MPa / Pass, Ultimate Elongation: 331
Physical properties (ASTM D412) Before Aging: Tensile Strength: 12589% / Pass19MPa / Pass, Ultimate Elongation: 325~544% / Pass
Physical properties (ASTM D412) After Aging: Tensile Strength: 11
Cytotoxicity (ISO 10993-5): Under conditions of the study, device extract is not cytotoxic. / Pass
Irritation (ISO 10993-10): Under the conditions of the study, not an irritant. / Pass
Sensitization (ISO 10993-10): Under conditions of the study, not a sensitizer. / Pass
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.
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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.
September 28, 2022
Anhui Bytech Medical Supplies Co., Ltd. % Boyle Wang Consultant Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K222442
Trade/Device Name: Disposable Vinyl Examination Gloves (Pink, Black, Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: July 8, 2022 Received: August 12, 2022
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 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) K222442
Device Name DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
Indications for Use (Describe)
The DISPOSABLE VINYL EXAMINATION GLOVE (Pink, Black, Blue) 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 - K222442
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
ANHUI BYTECH MEDICAL SUPPLIES CO., LTD. Name: Address: LingBi Economic Development Zone (North), SuZhou City, Anhui Provice, China. Phone Number: +86-15212555271 Contact: Lijun Chen Date of Preparation: Jul.8, 2022
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: | DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) |
|---|---|
| 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: | ZHICHENG TRADING CO., LTD. |
|---|---|
| Device: | Vinyl Examination Glove (Clear, Non-Colored) |
| 510(k) number: | K180861 |
5.0 Indication for Use
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The DISPOSABLE VINYL EXAMINATION GLOVE (Pink, Black, Blue) 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 examination glove. The subject device's color is pink, black and blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device
(K222442) | Predicated Device
(K180861) | Remark |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The DISPOSABLE
VINYL EXAMINATION
GLOVES(Pink, Black,
Blue) 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 (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 |
| Material | Vinyl | Vinyl | Same |
| Powdered or
Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Pink, black, blue | Clear | Different
Analysis 1 |
| Labeling
Information | Single-use indication,
powder free, device
color, device name,
glove size and quantity,
Non-Sterile | Single-use indication,
powder free, device
color, device name,
glove size and quantity,
Non-Sterile | Same |
| Dimensions(mm) | Length:
S/M/L/XL: ≥230;
Width:
S: 85±5;
M: 95±5; | Length:
S≥230;
M≥235;
L≥245;
XL≥245; | Similar
Analysis 2 |
Table1-General Comparison
5
| | | L: 105±5;
XL: 115±5 | Width:
S: 85±5;
M: 95±5;
L: 105±5;
XL: 115±5 | | | |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-----------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------|--------------------|
| Thickness(mm) | | Finger: ≥0.08;
Palm: ≥0.08 | Finger: ≥0.05;
Palm: ≥0.08 | Similar Analysis 2 | | |
| Physical
Properties | Before
Aging | Tensile Strength
Ultimate Elongation | 11MPa, min
300% min | Tensile Strength
Ultimate Elongation | 15MPa, min
380% min | Similar Analysis 3 |
| | After
Aging | Tensile Strength
Ultimate Elongation | 11MPa, min
300%min | Tensile Strength
Ultimate Elongation | 15MPa, min
380%min | Similar Analysis 3 |
| | | Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151
AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151
AQL=1.5 | Similar Analysis 4 | |
| | Powder Content | Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Same | | |
| Biocompatibility | ISO 10993-10;
Under the conditions of the study, not an irritant or a sensitizer | Comply with ISO10993-10 | Same | | | |
| Under conditions of the study, did not show potential toxicity to L-929 cells. Complies with ISO 10993-5 | Under conditions of the study, did not show potential toxicity to L-929 cells. Complies with ISO 10993-5 | Same | | | | |
Analysis 1:
The subject device (pink, black, blue) has different color to the predicate device (clear), but all proposed devices are conducted the biocompatibility test.
Analysis 2:
The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250.
Analysis 3:
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
6
Analysis 4:
Freedom from holes of subject device is similar with that of the predicate, but they all meet the requirements of ASTMD5151.
8.0 Summary 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 10993-5 Third edition 2009-06-01, 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.
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
| Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM | |||
| D5250 | Physical | ||
| Dimensions | |||
| Test | Length(mm): | ||
| S/M/L/XL: ≥230; | |||
| Width(mm): | |||
| S: 85±5; | |||
| M: 95±5; | |||
| L: 105±5; | |||
| XL: 115±5 | |||
| Thickness (mm): | |||
| Finger: ≥0.08 | |||
| Palm: ≥0.08 | Length(mm): |
230/Pass;
Width(mm):
S: 83-87 / Pass
M: 92-97/ Pass
L: 104-106/ Pass
XL: 112-117/ Pass
Thickness (mm):
Finger:0.13-0.14/ Pass
Palm:0.09-0.11/Pass |
| ASTM
D5151 | Watertightness
Test for
Detection of
Holes | Meet the requirements of ASTM
D5151 AQL 2.5 | 0/125 / Pass |
Table 2 - Summary of non-clinical performance testing
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| ASTM
D6124 | Powder
Content | Meet the requirements of ASTM
D6124