Single-use medical poly (vinyl chloride) examination glove

K201504 · Anhui Bytech Medical Supplies Co., Ltd. · LYZ · May 10, 2021 · General Hospital

Device Facts

• Record ID: K201504
• Device Name: Single-use medical poly (vinyl chloride) examination glove
• Applicant: Anhui Bytech Medical Supplies Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: May 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Single-use medical poly (vinyl chloride) examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, poly (vinyl chloride) examination glove; worn on examiner's hands. Acts as physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings. Ambidextrous design; smooth surface; clear/non-colored. Provides protection during medical examinations. Benefits patient and clinician by reducing risk of contamination.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D5250 (dimensions/physical properties), ASTM D6124 (residual powder), and ASTM D5151 (freedom from holes, AQL 1.5). Biocompatibility verified via ISO 10993-10 (irritation/sensitization) and ISO 10993-5 (cytotoxicity).

Technological Characteristics

Material: Poly (vinyl chloride). Form factor: Ambidextrous, smooth, clear, non-sterile glove. Standards: ASTM D5250 (dimensions/physical properties), ASTM D6124 (residual powder), ASTM D5151 (freedom from holes), ISO 10993-5/10 (biocompatibility). No energy source or software.

Indications for Use

Indicated for use as a disposable, non-sterile, ambidextrous, powder-free vinyl examination glove worn by medical examiners to prevent cross-contamination between patient and examiner.

Regulatory Classification

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.

Predicate Devices

• Vinyl Examination Glove (Clear, Non-Colored) (K180849)

Submission Summary (Full Text)

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May 10, 2021

Anhui Bytech Medical Supplies Co., Ltd. % Ivy Wang Technical Manager Shanghai SUNGO Management Consultanting Co., Ltd. 13th F, 1500# Century Avenue Shanghai, Shanghai 200122 China

Re: K201504

Trade/Device Name: Single-use medical poly (vinyl chloride) examination glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: June 5, 2020 Received: June 5, 2020

Dear Ivy 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 and Part medical device reporting (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Clarence W. Murray III, Ph.D. Acting 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) K201504

#### Device Name

Single-use medical poly (vinyl chloride) examination glove

Indications for Use (Describe)

The Single-use medical poly (vinyl chloride) examination glove 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

K201504 Date of preparation: 05 -10-2021

#### A. Applicant

Name: ANHUI BYTECH MEDICAL SUPPLIES CO., LTD. Address: LingBi Economic Development Zone (North), SuZhou City, Anhui Provice Name: Mr. Cheng Wang Tel: [phone] Fax: [phone]

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: fda.sungo@@gmail.com

#### B. Device

Trade Name: Single-use medical poly (vinyl chloride) examination glove Common Name: Vinyl Patient Examination Gloves (Powder Free) Model(s): XS, S, M, L, XL

Regulatory Information Classification Name: Vinyl Patient Examination Gloves (Powder Free) Classification: Class I. Product code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

#### C. Predicate device

| Sponsor | HUIFU TRADING CO., LTD. |
|-------------|----------------------------------------------|
| Device Name | Vinyl Examination Glove (Clear, Non-Colored) |

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| 510(k) Number | K180849 |
|-------------------|----------|
| Product Code | LYZ |
| Regulation Number | 880.6250 |
| Regulation Class | I |

#### D. Indications for use of the device:

The Single-use medical poly (vinyl chloride) examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

#### E. Device Description:

The proposed device is Powder Free Vinyl Patient Examination Gloves which is made of poly vinyl chloride. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

#### F. Comparison with predicate device

#### Table 1 General Comparison

| ITEM | Proposed Device<br>(K201504) | Predicate Device (K180849) | Remark |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LYZ | LYZ | SAME |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
| Intended Use | The Single-use medical poly<br>(vinyl chloride) examination<br>glove is a disposable device<br>intended for medical purposes<br>that is worn on the examiner's<br>hands to prevent contamination<br>between patient and examiner. | The Vinyl Patient Examination<br>Glove(Clear, Non-Colored) is a<br>disposable device intended for<br>medical purposes that is worn on the<br>examiner's hands to prevent<br>contamination between patient and<br>examiner. | SAME |
| Powdered or<br>Powered free | Powdered free | Powdered free | SAME |
| Design Feature | ambidextrous | ambidextrous | SAME |
| Surface Feature | Smooth | Smooth | SAME |
| Device Materials | Vinyl | Vinyl | SAME |
| Color | Clear | Clear | SAME |

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| Labeling<br>Information | Single-use indication, powder free, device color, device name glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | SAME |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------|
|-------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------|

### Table 2 Device Dimensions Comparison

| ITEM | Proposed Device (K201504) | | | | | Predicate Device (K180849) | | | | Remark |
|---------------|---------------------------|------|------|-------|-------|----------------------------|----------------|----------------|----------------|----------|
| Size | XS | S | M | L | XL | S | M | L | XL | similar |
| Length, mm | Minimum 230 | | | | | Minimum<br>230 | Minimum<br>235 | Minimum<br>245 | Minimum<br>245 | similar |
| Width, mm | 78±3 | 85±3 | 95±3 | 105±3 | 115±3 | 85±5 | 95±5 | 105±5 | 115±5 | similar |
| Thickness, mm | Finger: minimum 0.05 | | | | | Finger: minimum 0.08 | | | | Differer |
| | Palm: minimum 0.08 | | | | | Palm: minimum 0.08 | | | | Same |

Discussion: The proposed device has slight difference on the dimensions of Length, width and finger thickness to the predicate device. However, the testing results meet the specification as stated in ASTM D5250. This difference will not affect the safety and effectiveness of the proposed device.

#### Table 3 Performance Comparison

| ITEM | Proposed Device<br>(K201504) | Predicate Device<br>(K180849) | Remark |
|------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------|---------|
| Colorant | Clear, Non-Colored | Clear, Non-Colored | Same |
| Physical<br>Properties | Before Aging | | Similar |
| | Tensile Strength | 11 MPa, min | |
| | Ultimate Elongation | 300 % min | |
| | After Aging<br>Tensile Strength<br>Ultimate Elongation | 11 MPa, min<br>300 % min | |
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 AQL = 1.5 | Be free from holes when tested in accordance with ASTM D5151 AQL =1.5 | Same |

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| Powder Content | Meets Applicable Definition for<br>Powder Free: ≤ 2 mg per glove | 0.5 mg | Similar |
|----------------|------------------------------------------------------------------|--------|---------|
|----------------|------------------------------------------------------------------|--------|---------|

Discussion: The proposed device has slight difference on the performance of physical properties and powder content to the predicate device. However, the testing results meet the specification as stated in ASTM D5250 and ASTM D6124. This difference will not affectiveness of the proposed device. The proposed device use the same AQL=1.5 as the predicate device, which is the requirement for European market and also meet the specification as stated in ASTM D5151. This will not affect the safety and effectiveness of the proposed device.

#### Table 4 Safety Comparison

| ITEM | Predicate Device (K180849) | Proposed Device (K201504) | Remark | |
|--------------------|----------------------------|---------------------------|--------------------------------------------------------------------------------|--|
| Biocompatibility | Irritation | Comply with ISO 10993-10 | Under the conditions of the study not an irritant | |
| | Sensitization | | Under conditions of the study, not a sensitizer. | |
| | Cytotoxicity | Comply with ISO 10993-5 | Under conditions of the study, did not show potential toxicity to L-929 cells. | |
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | Same | |

#### G. Summary of non-clinical performance testing

| Test item | Test method | Pass criteria | Test results/ Verdict | |
|--------------------------------|----------------------------|---------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Dimension<br>(mm) | Overall Length | ASTM D5250 | Min 230 | >230/ Pass |
| | Width | | XS: 76±6<br>S: 85±5<br>M: 95±5<br>L: 105±5<br>XL: 115±5 | XS: 79-81/ Pass<br>S: 85-87 /Pass<br>M: 95-97/ Pass<br>L: 105-107/ Pass<br>XL: 115-117/ Pass |
| | Finger thickness | | 0.05 | 0.09-0.12/ Pass |
| | Palm thickness | | 0.08 | 0.08-0.09/ Pass |
| | | | | |
| Freedom from Holes | ASTM D5151 | Meet the<br>requirements of ASTM<br>D5151 AQL 1.5 | 0/125, 1/ 125, 4/315,<br>5/500, 3/200 leaks /<br>Pass | |
| Powder Content | ASTM D6124 | Meet the requirements of<br>ASTM D6124 < 2.0mg | 0.3 – 0.42/ Pass | |
| Physical<br>properties | Tensile Strength<br>(MPa) | ASTM D412 | Meet the requirements<br>of ASTM D412 Min 11 | 14-19/ Pass |
| | Ultimate<br>Elongation (%) | | Meet the requirements of<br>ASTM D412 Min 300% | 390 – 430/ Pass |
| Biocompatibility<br>Irritation | ISO 10993-10 | Non-irritating | Under the conditions of | |

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| | | | | the study, not an irritant/ Pass |
|--|---------------|--------------|-----------------|--------------------------------------------------------------------------------------|
| | Sensitization | ISO 10993-10 | Non-sensitizing | Under conditions of the study, not a sensitizer./ Pass |
| | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells./ Pass |

Biocompatibility testing:

- Skin sensitization & Irritation -- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part A 10: Tests For Irritation And Skin Sensitization.
- A Cytotoxicity -- ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

Performance testing:

- > Residue Powder -- ASTM D6124-06 (Reaffirmation 2017), Standard Test Method for Residual Powder on Medical Gloves
- A Freedom from holes -- ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves.
- > Physical properties & Dimensions -- ASTM D5250-06 (Reapproved 2015), Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
- A ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-LotInspection.

#### H. Summary of Clinical Performance Test

No clinical study is included in this submission.

#### l. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K201504, the Single-use medical poly (vinyl chloride) examination glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K180849.