Disposable Nitrile Examination Gloves (Powder free, Blue)

K211581 · Leping Shengde Medical Technology Company Limited · LZA · Oct 28, 2021 · General Hospital

Device Facts

• Record ID: K211581
• Device Name: Disposable Nitrile Examination Gloves (Powder free, Blue)
• Applicant: Leping Shengde Medical Technology Company Limited
• Product Code: LZA · General Hospital
• Decision Date: Oct 28, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue) 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 nitrile examination gloves; worn on examiner's hands; barrier to prevent cross-contamination between patient and examiner. Used in clinical settings; non-sterile. Device provides physical barrier protection; material properties (tensile strength, elongation) and pinhole resistance verified against ASTM standards. Benefits patient and clinician by reducing risk of contamination during examinations.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ASTM D6319 (physical dimensions, tensile strength, elongation), ASTM D5151 (pinhole/freedom from holes), and ASTM D6124 (residual powder). Biocompatibility testing per ISO 10993-10 (irritation, sensitization) and ISO 10993-11 (systemic toxicity) confirmed no adverse responses.

Technological Characteristics

Material: Nitrile. Form factor: Disposable, powder-free, blue, non-sterile. Dimensions and physical properties comply with ASTM D6319. Biocompatibility verified per ISO 10993-10 and ISO 10993-11.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands to prevent 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

• POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) (K150340)

Reference Devices

• Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) (K210898)

Submission Summary (Full Text)

{0}------------------------------------------------

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.

October 28, 2021

Leping Shengde Medical Technology Company Limited % 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: K211581

Trade/Device Name: Disposable Nitrile Examination Gloves (Powder free, Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 30, 2021 Received: October 6, 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.

{1}------------------------------------------------

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 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. 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K211581

Device Name

DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue)

Indications for Use (Describe)

The DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 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: K211581

- 1. Date of Preparation: 10/28/2021
- 2. Sponsor

### LEPING SHENGDE MEDICAL TECHNOLOGY COMPANY LIMITED

No.17, Yubao Village, Lingang Village Committee, Lingang Town, Leping City, Jingdezhen City, Jiangxi Province, China, 333300 Contact Person: Sheng Jianchao Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. 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: [phone] Fax: [phone] Email: [e-mail]

- Proposed Device Identification 4.
Trade Name: DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue) Common Name: NITRILE Patient Examination Gloves (Powder Free) Regulatory Information: Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

{4}------------------------------------------------

Indication For Use Statement:

The DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue) 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 5.
Primary Predicate Device 510(k) Number: K150340 Product Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) Manufacturer: HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD

Reference Device 510(k) Number: K210898 Product Name: Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) Manufacturer: Tangshan Lanhai Medical Supplies Co., Ltd.

- 6. Device Description
The proposed device, DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.

The proposed device is not provided as sterilized The proposed device is made of Nitrile.

| Table 1 Device Size Specifications | | | | | | |
|------------------------------------|---------------------------|---------------------------|-----------------------------|---------------|----------------|-------|
| Size<br>Model | Cuff<br>Thickness<br>(mm) | Palm<br>Thickness<br>(mm) | Finger<br>Thickness<br>(mm) | Width<br>(mm) | Length<br>(mm) | Color |
| S | $\ge 0.05$ | $\ge 0.05$ | $\ge 0.05$ | 80±10 | $\ge 220$ | |
| M | $\ge 0.05$ | $\ge 0.05$ | $\ge 0.05$ | 95±10 | | Blue |
| L | $\ge 0.05$ | $\ge 0.05$ | $\ge 0.05$ | 110±10 | $\ge 230$ | |
| XL | $\ge 0.05$ | $\ge 0.05$ | $\ge 0.05$ | 120±10 | | |

T.1.1. 1 D .. ત:

Table 2 Performance and Physical Specifications

| Before Aging | | After Aging | | Pinhole AQL |
|--------------|----------|-------------|----------|-------------|
| Tensile | Ultimate | Tensile | Ultimate | 1.5 |

{5}------------------------------------------------

| Strength | Elongation | Strength | Elongation |
|-------------|------------|-------------|------------|
| 14 MPa, min | 500 % min | 14 MPa, min | 400 % min |

The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319.

- 7. Comparison of technological characteristics between the subject and predicate devices

| Table 1 General Comparison |
|----------------------------|
| |

| | Proposed Device | Predicate Device (K150340) | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| ITEM | DISPOSABLE NITRILE EXAMINATION<br>GLOVES (Powder free, Blue) | POWDER FREE Nitrile GLOVES (White,<br>Cobalt Blue, Black, Ice Blue) | Remark |
| Product Code | LZA | LZA | SAME |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
| Intended Use | The DISPOSABLE NITRILE<br>EXAMINATION GLOVES (Powder free,<br>Blue) is a disposable device intended for<br>medical purposes that is worn on the<br>examiner's hands to prevent contamination<br>between patient and examiner. | The POWDER FREE Nitrile GLOVES<br>(White, Cobalt Blue, Black, Ice Blue) is a<br>disposable device intended for medical<br>purposes that is worn on the examiner's<br>hands to prevent contamination between<br>patient and examiner. | SAME |
| Powdered or<br>Powered free | Powdered free | Powdered free | SAME |

{6}------------------------------------------------

| Proposed Device | Designation | Size | | | | Tolerance | |
|------------------------------------------------------------------------|-------------|-----------|----|-----|-----|-----------|-----------|
| DISPOSABLE NITRILE<br>EXAMINATION GLOVES<br>(Powder free, Blue) | Length, mm | S | M | L | XL | min | |
| | Width, mm | 80 | 95 | 110 | 120 | ±10 | |
| Thickness, mm: | | | | | | | |
| | Finger | 0.05 | | | | min | |
| | Palm | 0.05 | | | | min | |
| | Cuff | 0.05 | | | | min | |
| Predicate Device (K150340) | Designation | Size | | | | | Tolerance |
| POWDER FREE Nitrile<br>GLOVES (White, Cobalt Blue,<br>Black, Ice Blue) | Length, mm | XS | S | M | L | XL | min |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 |
| Thickness, mm: | | | | | | | |
| | Finger | 0.10-0.12 | | | | | ±0.03 |
| | Palm | 0.08-0.10 | | | | | ±0.03 |
| | Cuff | 0.06-0.09 | | | | | ±0.03 |
| Reference Device | Designation | Size | | | | Tolerance | |
| DISPOSABLE NITRILE<br>EXAMINATION GLOVES<br>(Powder free, Blue) | Length, mm | S | M | L | XL | min | |
| | Width, mm | 80 | 95 | 110 | 120 | ±10 | |
| Thickness, mm: | | | | | | | |
| | Finger | 0.05 | | | | min | |
| | Palm | 0.05 | | | | min | |
| | Cuff | 0.05 | | | | min | |
| Remark | Similar | | | | | | |

Table 2 Device Dimensions Comparison

Different Analysis:

The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D 6319.

| ITEM | Proposed Device | Predicate Device (K150340) | Reference Device (K210898) | Remark |
|------|-----------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------|--------|
| ITEM | DISPOSABLE NITRILE<br>EXAMINATION GLOVES<br>(Powder free, Blue) | POWDER FREE Nitrile<br>GLOVES (White, Cobalt<br>Blue, Black, Ice Blue) | DISPOSABLE NITRILE<br>EXAMINATION | Remark |

Table 3 Performance Comparison

{7}------------------------------------------------

| | | | | | GLOVES (Powder free,<br>Blue) | |
|------------------------|-----------------|------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------|
| | | | | | Purple-Blue, Blue | Different |
| Physical<br>Properties | Colorant | | Blue | White, Cobalt Blue, Black,<br>Ice Blue | | |
| | Before<br>Aging | Tensile<br>Strength | 14 MPa, min | 15 MPa, min | 14 MPa, min | Different |
| | | Ultimate<br>Elongation | 500 % min | 500 % min | 500% min | SAME |
| | | | | | | |
| | After<br>Aging | Tensile<br>Strength | 14 MPa, min | 14 MPa, min | 14 MPa min | SAME |
| | | Ultimate<br>Elongation | 400 % min | 400 % min | 400% min | SAME |
| | | | | | | |
| | | | | Comply with ASTM D6319 | Comply with ASTM D6319 | Comply with ASTM<br>D6319 |
| | | | | | | |
| Freedom from Holes | | | Be free from holes when tested<br>in accordance with ASTM<br>D5151<br>AQL 1.5 | Be free from holes when<br>tested in accordance with<br>ASTM D5151<br>AQL 1.5 | Be free from holes when<br>tested in accordance with<br>ASTM D5151<br>AQL 2.5 | SAME |
| Powder Content | | | Less than 2 mg per glove when<br>tested in accordance with ASTM<br>D6124 | Meet the requirements of<br>ASTM 6124 | Meet the requirements of<br>ASTM 6124 | SAME |

Different Analysis:

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 10993-10 and ISO 10993-11 and the test results showed that the proposed devices did not induce skin irritation and showed no significant evidence of causing skin sensitization and systemic toxicity response. Different Analysis:

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 6319.

| Table 4 Safety Comparison | | |
|---------------------------|--|--|
| | | |

| ITEM | | Proposed Device | Predicate Device (K150340) | Reference Device<br>(K210898) | Remark |
|------------------|---------------|-----------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------|--------|
| Material | | Nitrile | Nitrile | Nitrile | SAME |
| Biocompatibility | Irritation | Under the conditions of the<br>study, not an irritant | Under the conditions of the<br>study, not an irritant | Under the conditions of the<br>study, not an irritant | SAME |
| | Sensitization | Under conditions of the | Under conditions of the study, | Under conditions of the | |
| | | DISPOSABLE NITRILE<br>EXAMINATION GLOVES<br>(Powder free, Blue) | POWDER FREE Nitrile<br>GLOVES (White, Cobalt<br>Blue, Black, Ice Blue) | DISPOSABLE NITRILE<br>EXAMINATION<br>GLOVES (Powder free,<br>Blue) | |

{8}------------------------------------------------

| | | study, not a sensitizer. | not a sensitizer. | study, not a sensitizer. | |
|--------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------|-----------|
| | acute<br>systemic<br>toxicity | Under the conditions of the<br>study,<br>there was no evidence of<br>systemic toxicity from the<br>extract. | Not Available | Under the conditions of the<br>study,<br>there was no evidence of<br>systemic toxicity from the<br>extract. | Different |
| Label and Labeling | | Meet FDA's Requirements | Meet FDA's Requirements | Meet FDA's Requirements | SAME |

### Different Analysis:

The proposed device has conducted the acute systemic toxicity testing, and the test results showed that there was no evidence of systemic toxicity.

- Summary of Non-Clinical Testing 8.
Bench 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:

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 D6124-17, Standard Test Method for Residual Powder on Medical Gloves.

ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

| Test Method | Purpose | Acceptance Criteria | Results |
|-------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D5151 | Testing for Freedom from holes | Freedom from holes<br>AQL 2.5 | No water leakage is inspected form 200 samples |
| ASTM D6124 | Determine the powder residue for powder free gloves | <2.0 mg per glove | Residual Powder of Size S: Average 0.36 mg;<br>Residual Powder of Size M: Average 0.37 mg;<br>Residual Powder of Size L: Average 0.34 mg;<br>Residual Powder of Size XL: Average 0.32mg; |
| ASTM D412<br>ASTM D573 | Testing for Physical property characteristics | Before Aging<br>Tensile Strength: 14 MPa min.<br>Ultimate Elongation: 500% min.<br>Before Aging<br>Tensile Strength: 14 MPa min.<br>Ultimate Elongation: 400% min. | Before Aging<br>Tensile Strength: $\ge$ 19MPa;<br>Ultimate Elongation: $\ge$ 500%.<br>After Aging<br>Tensile Strength: $\ge$ 18 MPa;<br>Ultimate Elongation: $\ge$ 472%. |
| ASTM D412<br>ASTM D3767 | Testing For physical dimensions specification | Length: 220 mm min. for size (S);<br>Length: 230 mm min. for size (M, L, XL);<br>80±10 mm for S; 95±10 mm for M; | Length of Size S: $\ge$ 223mm;<br>Width of Size S: 85±2 (85-87) mm;<br>Cuff Thickness of Size S: $\ge$ 0.06 mm;<br>Palm Thickness of Size S: $\ge$ 0.07 mm; |

Table 5 Performance Test Results Summary

{9}------------------------------------------------

| | | 110 $\pm$ 10 mm for L; 120 $\pm$ 10 mm for XL. | Finger Thickness of Size S: $\geq$ 0.10 mm. |
|--------------|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| | | Cuff Thickness: $\geq$ 0.05 mm; | |
| | | Finger Thickness: $\geq$ 0.05 mm; | Length of Size M: $\geq$ 231 mm; |
| | | Palm Thickness: $\geq$ 0.05 mm; | Width of Size M: 95 $\pm$ 3 (95-97) mm; |
| | | All acceptance criteria above meet the | Cuff Thickness of Size M: $\geq$ 0.06 mm; |
| | | requirements in Table 1 Dimensions and | Palm Thickness of Size M: $\geq$ 0.07 mm; |
| | | Tolerances of ASTM D6319 | Finger Thickness of Size M: $\geq$ 0.10 mm. |
| | | | Length of Size L: $\geq$ 231mm; |
| | | | Width of Size L: 107 $\pm$ 2 (105-109) mm; |
| | | | Cuff Thickness of Size L: $\geq$ 0.06 mm; |
| | | | Palm Thickness of Size L: $\geq$ 0.07 mm; |
| | | | Finger Thickness of Size L: $\geq$ 0.10 mm. |
| | | | |
| | | | |
| | | | Length of Size XL: $\geq$ 233mm; |
| | | | Width of Size XL: 121 $\pm$ 6 (115-127) mm; |
| | | | Cuff Thickness of Size XL: $\geq$ 0.06 mm; |
| | | | Palm Thickness of Size XL: $\geq$ 0.07 mm; |
| | | | Finger Thickness of Size XL: $\geq$ 0.10 mm. |
| | | | |
| ISO 10993-11 | Evaluate the endpoint of<br>Cytotoxicity for<br>biocompatibility | The test article showed no evidence of<br>cytotoxic potential from the extract. | The test article showed no evidence of<br>systemic toxicity from the extract. |
| ISO 10993-10 | Evaluate the endpoint of<br>irritant for<br>biocompatibility | The response of the test article extract is<br>negligible. | The test result showed that the response of the<br>test article extract was categorized as<br>negligible under the test condition. |
| | Evaluate the endpoint of<br>sensitization for<br>biocompatibility | The test article showed no evidence of<br>causing delayed dermal contact<br>sensitization. | The test article showed no evidence of causing<br>delayed dermal contact sensitization in the<br>guinea pig. |

- 9. Summary of Clinical Testing Clinical Testing is not applicable.
## 10. Conclusion

Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) cleared under K150340.