Medical Gloves

K203622 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · LZA · Aug 20, 2021 · General Hospital

Device Facts

• Record ID: K203622
• Device Name: Medical Gloves
• Applicant: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 20, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, powder-free patient examination glove; manufactured from nitrile latex compound; blue color. Available in five sizes (XS, S, M, L, XL). Worn by clinicians or examiners to provide a barrier against contamination between patient and examiner. Device functions as a physical barrier; no electronic or software components. Performance verified against ASTM D6319-19 standards for dimensions, physical properties, and freedom from holes.

Clinical Evidence

Bench testing only. No clinical data. Testing included freedom from holes (ASTM D5151-19), physical dimensions (ASTM D6319-19), physical properties (ASTM D412-16), residual powder (ASTM D6124-06), and biocompatibility (ISO 10993-10 for irritation/sensitization and ISO 10993-11 for acute systemic toxicity). All results met acceptance criteria.

Technological Characteristics

Material: Nitrile latex compound. Form factor: Disposable, non-sterile, powder-free glove. Sizes: XS, S, M, L, XL. Standards: ASTM D6319-19 (Nitrile Examination Gloves), ASTM D5151-19 (Holes), ASTM D412-16 (Tension), ASTM D6124-06 (Residual Powder), ISO 10993-10/11 (Biocompatibility). No energy source, connectivity, or software.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands or fingers 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

• SBG Blue Nitrile Powder Free Medical Examination Glove (K180467)

Submission Summary (Full Text)

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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.

August 20, 2021

Beijing Biosis Healing Biological Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China

Re: K203622

Trade/Device Name: Medical Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 10, 2021 Received: July 19, 2021

Dear Diana Hong:

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 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 ([e-mail]) or phone [phone] 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K203622

Device Name Medical Gloves

Indications for Use (Describe)

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on 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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# 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K203622

- 1. Date of Preparation: 08/19/2021
- 2. Sponsor Identification

# Beijing Biosis Healing Biological Technology Co., Ltd. No.6 Plant West, Valley No.1 bio-medicine Industry Park, Daxing District, Beijing, 102600, China.

Establishment Registration Number: 3016668451

Contact Person: Ting Jiang Position: RA Director Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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## K203622

- Identification of Proposed Device 4.
Trade Name: Medical Gloves Common Name: Patient Examination Glove

Regulatory Information Classification Name: Non-powderedpatient examination glove Classification: I; Product Code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

Indication for use:

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Description:

The proposed device is a powder free medical glove. The device is made from a nitrile latex compound, blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The device is available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The device can be provided in non-sterile.

- ર. Identification of Predicate Device
510(k) Number: K180467 Product Name: SBG Blue Nitrile Powder Free Medical Examination Glove

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- 6. Technological Comparison:

| ITEM | Proposed Device | Predicate Device | Remark |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | K203622 | K180467 | Same |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | Class I | Class I | Same |
| Indication for use | A powder free patient examination<br>glove is a disposable device<br>intended for medical purposes that<br>is worn on the examiner's hands or<br>fingers to prevent contamination<br>between patient and examiner. | A powder free patient<br>examination glove is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hands or fingers to<br>prevent contamination between<br>patient and examiner. | Same |
| Material | Nitrile latex compound | Nitrile latex compound | Same |
| Color | Blue | Blue | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Model | XS, S, M, L, XL | S, M, L, XL | Analysis 1 |
| Dimensions<br>(ASTM D6319-19) | > 220 mm (XS and S sizes)<br>> 230 mm (M, L and XL sizes)<br>Width(±10mm)<br>XS = 70mm<br>S = 80mm<br>M = 95mm<br>L = 110mm<br>XL = 120mm<br>Thickness at Finger (mm)<br>All Sizes ≥ 0.05 mm<br>Thickness at Palm<br>All Sizes ≥ 0.05 mm | Overall Length (mm)<br>220 mm = (sizes XS-S)<br>230 mm = (sizes M-XL)<br>Width (± 10 mm)<br>Size S = 80 mm<br>Size M = 95 mm<br>Size L = 110 mm<br>Size XL = 120 mm<br>Thickness at Finger (mm)<br>All Sizes = 0.05 mm<br>Thickness at Palm<br>All Sizes = 0.05 mm | Analysis 2 |
| Physical Properties<br>(ASTM D6319-19<br>and<br>ASTM<br>D412-16) | Before Aging<br>Tensile Strength ≥ 14Mpa<br>Ultimate Elongation ≥ 500%<br>After Aging<br>Tensile Strength ≥ 14Mpa<br>Ultimate Elongation ≥ 400% | Before Aging<br>Tensile Strength ≥ 14Mpa<br>Ultimate Elongation ≥ 500%<br>After Aging<br>Tensile Strength ≥ 14Mpa<br>Ultimate Elongation ≥ 400% | Analysis 3 |
| Powder free residue<br>(ASTM D6319-19 and ASTM D6124-06) | Less than 2 mg per glove | Less than 2 mg per glove | Analysis 4 |
| Freedom from Holes<br>(ASTM D5151-19) | AQL 2.5 Inspection<br>Level G-1<br>Accept at 5 failures<br>Reject at 6 failures<br>Meets ASTM D5151-19 | AQL 2.5 Inspection<br>Level G-1<br>Accept at 5 failures<br>Reject at 6 failures<br>Meets ASTM D5151-06 | Analysis 5 |
| Skin Irritation | No Irritation | No Irritation | Same |
| Sensitization | No Sensitization | No Sensitization | Same |
| Acute toxicity | No acute toxicity | / | Analysis 6 |

Table 1 General
Technological Comparison

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## Analysis 1 - Model

The proposed device has the additional XS size compared to predicate device. A various sizes could provide more choices for users and the different size does not affect intended use. In addition, the size XS of proposed device has been tested and the test result demonstrated that it could meet the requirements of ASTM D6319-19. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.

### Analysis 2 - Dimensions

The dimensions of proposed device are different from predicate device 1. The proposed device has one more XS size and the minimum length of proposed device is larger than the predicate device 1. In addition, the proposed device was tested according to the ASTM D6319-19 while the predicate device 1 was tested according to ASTM D6319-10. However, these two standards are just different in version and all test results of dimensions for proposed device could met the requirements of ASTM D6319 -19. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.

#### Analysis 3 - Physical Properties

The standard version of Physical Properties requirements for the proposed device is different from the predicated device 1. The proposed device was tested and met the requirements of ASTM D6319 -19 while the predicate device 1 was tested and met the requirements of ASTM D6319-10. However, these two standards are just different in version. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.

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## Analysis 4 - Powder free residue

The standard version of Powder free residue requirements for the proposed device is different from the predicated device 1. The proposed device was tested and met the requirements of ASTM D6319 -19 while the predicate device 1 was tested and met the requirements of ASTM D6319-10. However, these two standards are just different in version. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.

### Analysis 5 - Freedom from Holes

The standard version of Freedom from Holes requirements for the proposed device is different from the predicated device 1. The proposed device was tested and met the requirements of ASTM D5151 -19 while the predicate device 1 was tested and met the requirements of ASTM D5151-06. However, these two standards are just different in version. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.

### Analysis 6-Biocompabitlity

The contact level and duration for the proposed device is intact skin and limited contact. Cytotoxicity, Skin sensitization and irritation shall be evaluated for the proposed device per FDA guidance. Acute toxicity test was evaluated for the proposed device instead of cytotoxicity. The test result showed that there was no adverse effect. Therefore, it can be considered that the proposed device is safety as the predicate device.

#### 7. Non-Clinical Testing:

Non clinical tests were conducted to provide data that the proposed devices met the acceptance criteria or the specification for the test methodology or standard shown below. The test results demonstrated that the proposed devices comply with the following standards:

- A ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- > ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- > ASTM D3767-03 Standard Practice for Rubber-Measurement of Dimensions
- > ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- A ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- A ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;

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| Test Method | Purpose | Acceptance Criteria | Results |
|-------------------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Freedom from Holes-ASTM<br>D5151 | Detection the holes that<br>allow water leakage | Do not show droplet, stream<br>or other type of water<br>leakage | No leakage |
| Physical dimension-ASTM<br>D6319 | Evaluate the glove<br>physical dimension | Length: >220 mm (XS and<br>S sizes)<br>Length: ><br>230 mm<br>(M, L and XL sizes)<br>Width (±10mm)<br>XS = 70mm<br>S = 80mm<br>M = 95mm<br>L = 110mm<br>XL = 120mm<br>Thickness at Finger (mm)<br>All Sizes ≥ 0.05 mm<br>Thickness at Palm<br>All Sizes ≥ 0.05 mm | Length<br>Larger than 220mm for<br>XS and S size<br>Larger than 230mm for<br>M, L and XL sizes<br>Width<br>XS: within 70±10mm<br>S: within 80±10mm<br>M: within 95±10mm<br>L: within 110±10mm<br>XL: within 120±10mm<br>Thickness<br>Larger than 0.05mm |
| Physical requirement-ASTM<br>D412 | Evaluate the physical<br>requirement | Before Aging (Min)<br>Tensile strength: 14Mpa<br>Ultimate elongation: 500%<br>After Aging (Min)<br>Tensile strength: 14Mpa<br>Ultimate elongation: 400% | Before aging<br>Larger than 14Mpa and<br>500%<br>After aging<br>Larger than 14Mpa and<br>400% |
| Powder residue-ASTM D6214 | Evaluate the residue<br>powder | Less than 2.0mg | Less than 2.0mg |
| Skin sensitization-ISO 10993-<br>10 | Evaluated for the potential<br>to cause delayed dermal<br>contact sensitization | Magnusson and Kligman<br>grade shall be less than<br>control group | No skin sensitization |
| Skin irritation-ISO 10993-10 | Evaluated for the potential<br>to cause skin irritation | No significant reaction than<br>the control group | No skin irritation |
| Acute toxicity-ISO 10993-11 | Evaluated for acute<br>systemic toxicity | No significant reaction than<br>the control group<br>Animal death or abnormal<br>behaviour no more than two<br>animals<br>Body weight loss greater<br>than 10% no more than 3<br>animals | No acute toxicity |

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#### 8. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K203622, the Medical Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K180467.