Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)

K221374 · Hebei Titans Hongsen Medical Technology Co., Ltd. · LYY · Oct 26, 2022 · General Hospital

Device Facts

• Record ID: K221374
• Device Name: Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
• Applicant: Hebei Titans Hongsen Medical Technology Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Oct 26, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Disposable Medical Rubber Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable natural rubber latex examination gloves; non-sterile; single-use. Worn by medical examiners to provide barrier protection against cross-contamination between patient and examiner. Manufactured to meet ASTM D3578-19 specifications. Subjected to bench testing for physical dimensions, tensile strength, elongation, freedom from holes, residual powder, and protein content. Biocompatibility verified via cytotoxicity, irritation, and sensitization testing. Used in clinical settings; provides barrier protection to reduce infection risk.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ASTM D3578-19 (physical properties, dimensions, freedom from holes), ASTM D6124 (residual powder), ASTM D5712 (protein content), and ISO 10993 series (biocompatibility: sensitization, irritation, systemic toxicity) demonstrated.

Technological Characteristics

Material: Natural rubber latex. Form factor: Disposable gloves, sizes XS-XL. Standards: ASTM D3578-19 (physical/dimensional), ASTM D5151 (holes), ASTM D6124 (powder), ASTM D5712 (protein), ISO 10993 (biocompatibility). Energy source: None (manual). Connectivity: None. Sterilization: Non-sterile.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand 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

• BEST GLOVE -LATEX POWDER FREE EXAMINATION GLOVE (K210253)

Submission Summary (Full Text)

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October 26, 2022

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, 102401 China

Re: K221374

Trade/Device Name: Disposable Medical Rubber Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LYY Dated: September 27, 2022 Received: September 27, 2022

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 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,

Bifeng Qian, M.D., 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) K221374

Device Name

Disposable Medical Rubber Examination Gloves

Indications for Use (Describe)

Disposable Medical Rubber Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)

X 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 K221374

- 1. Date of Preparation: 10/25/2022
- 2. Submitter

# Hebei Titans Hongsen Medical Technology Co., Ltd.

Eastern Industrial Zone, Nangong City, Xingtai City, 051800, Hebei, China

Contact Person: Chai Wu Position: Quality Director Tel: [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: information(@believe-med.com

- 4. Subject Device Identification
Trade Name: Disposable Medical Rubber Examination Gloves

Common Name: Latex Patient Examination Glove

Regulatory Information: Classification: I Product Code: LYY Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

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- న. Predicate Device Identification
#### K210253

# BEST GLOVE -LATEX POWDER FREE EXAMINATION GLOVE

#### BESTSAFE GLOVE CO., LTD

Regulatory Information:

Classification: I

Product Code: LYY

Regulation Number: 21 CFR 880.6250

Review Panel: General Hospital

Common Name: Latex Patient Examination Glove

- Device Description 6.
The Disposable Medical Rubber Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (no color is added) and are powder free.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

| Characteristics | Subject Device | | | | | | | | | | | | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|
| Single use | Single use | | | | | | | | | | | | |
| Sterile/Non Sterile | Non Sterile | | | | | | | | | | | | |
| Dimension | Length (mm): 230 min. | | | | | | | | | | | | |
| | Width (mm) | | | | | | | | | | | | |
| | Size Width XS 75 ± 5 S 85 ± 5 M 95 ± 5 L 105 ± 5 XL 115 ± 5 | | | | | | | | | | | | |
| | Thickness (mm) For all sizes: 0.08 min. | | | | | | | | | | | | |
| Physical Properties | Type I | | | | | | | | | | | | |
| | Before Aging After Accelerated Aging Tensile Strength 18MPa, min 14 MPa, min Ultimate Elongation 650 % min 500 % min | | | | | | | | | | | | |
| Freedom from holes | No water leakage is inspected. AQL 2.5 | | | | | | | | | | | | |
| Powder Free Residue | Size Residual powder content (mg/glove) XS 0.28 S 0.25 M 0.31 L 0.25 XL 0.35 | | | | | | | | | | | | |

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| Protein Content | Meet the requirements of ASTM D5712, Less than 200 $ \mu $ g/dm2 |
|------------------|----------------------------------------------------------------------------------------------|
| Biocompatibility | Biocompatible |

#### 7. Indication For Use Statement

Disposable Medical Rubber Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

- 8. Technological Characteristic Comparison Summary
The subject device has same indication for use, design (single use, non-sterile), powdered free and material with the predicate device.

The subject is different with the predicate device in dimensions, physical properties, powder free residue and protein content. But both subject device and predicate device meet the requirements of ASTM D3578-19, Standard Specification for Rubber Examination Gloves, so we conducted the testing as this standard, the test results show that the subject device meet the requirements of this standard, so these different in dimensions, physical properties, powder free residue and protein content would not raise new safety concerns.

| ITEM | References/Stand<br>ard | Proposed Device | Predicate Device K210253 | Remark |
|-----------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Intended Use | / | Disposable Medical Rubber Examination<br>Gloves are disposable device intended for<br>medical purpose that is worn on the examiner's<br>hand to prevent contamination between patient<br>and examiner. | A powder-free patient examination glove is a disposable<br>device intended for medical purposes that is worn on the<br>examiner's hand or finger to prevent contamination between<br>patient and examiner. | SAME |
| Material | / | Natural Rubber Latex | Natural Rubber Latex | SAME |
| Color | / | Natural White | Natural Color | SAME |
| OTC use | / | Yes | Yes | SAME |
| Single Use | / | Yes | Yes | SAME |
| Sterile | / | Non-sterile | Non-sterile | SAME |
| Dimension<br>(Length,<br>Width,Thickn<br>ess) | ASTM D3578<br>S-2 AQL 4.0 | Length (mm) min | Length (mm) min | Similar |
| | | Size | Size<br>Actual value | |
| | | XS | Small<br>240 | |
| | | S | Medium<br>240 | |
| | | M | Large<br>240 | |
| | | L | Extra Large<br>241 | |
| | | XL | / | |
| | | Width (mm) | Width (mm) | Similar |
| | | Size<br>Width | Size<br>Actual value | |
| | | XS<br>75 ± 5 | Small<br>85 ± 10 | |
| | | S<br>85 ± 5 | Medium<br>93 ± 10 | |
| | | M<br>95 ± 5 | Large<br>105 ± 10 | |
| | | L<br>105 ± 5 | Extra Large<br>115 ± 10 | |
| | | XL<br>115 ± 5 | / | |
| | | Thickness (mm) For all sizes min<br>Finger<br>0.08 | Thickness (mm) min | Similar |
| | | | Size<br>Palm<br>Actual value<br>Finger<br>Actual value | |

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| | | Palm | | 0.08 | | Small | 0.09 | | | 0.12 | | |
|------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------|----------------------|------|--------------------------------------------------------------------------------------------------------------|------------------------|----------------|-----------------|------------------------------------------|----------------------------|-----------------|---------|
| | | | | / | | Medium | 0.09 | | | 0.12 | | |
| | | | | / | | Large | 0.10 | | | 0.13 | | |
| | | | / | | / | | Extra<br>Large | 0.09 | | | 0.12 | |
| Physical<br>Properties | ASTM D412<br>S-2 AQL 4.0 | Type I | | | | Type I | | | | | | Similar |
| | | | Before<br>Aging | | After<br>Accelerated<br>Aging | | Before Aging | | | After Accelerated<br>Aging | | |
| | | Tensile<br>Strength | $18\text{MPa, min}$ | | $14\text{ MPa, min}$ | Tensile<br>Strength | Size | Actual<br>value | | Size | Actual<br>value | |
| | | | | | | | Small | 18.04 | | Small | 15.02 | |
| | | | | | | | Medium | 19.13 | | Medium | 18.12 | |
| | | | | | | | Large | 18.26 | | Large | 16.01 | |
| | | | | | | | Extra<br>Large | 18.64 | | Extra<br>Large | 15.06 | |
| | | Ultimate<br>Elongation | $650 \% \text{ min}$ | | $500 \% \text{ min}$ | Ultimate<br>Elongation | Size | Actual<br>value | | Size | Actual<br>value | |
| | | | | | | | Small | 651 | | Small | 501 | |
| | | | | | | | Medium | 654 | | Medium | 601 | |
| | | | | | | | Large | 650 | | Large | 501 | |
| | | | | | | | Extra<br>Large | 650 | | Extra<br>Large | 502 | |
| Freedom from<br>holes | ASTM D5151 | No water leakage is inspected.<br>I AQL 2.5 | | | Pass AQL 2.5 | | | | | SAME | | |
| Powder Free<br>Residue | ASTM D6124<br>N=5<br>Less than 2.0 mg/glove | Size | | | Residual powder<br>content<br>(mg/glove) | Size | | | Residual powder<br>content<br>(mg/glove) | | | Similar |
| | | XS | | 0.28 | | Small | | | 0.62 | | | |
| | | S | | 0.25 | | Medium | | | 0.46 | | | |
| | | M | | 0.31 | | Large | | | 0.61 | | | |
| | | L | | 0.25 | | Extra Large | | 0.61 | | | | |
| | | XL | | 0.35 | | / | | | / | | | |
| Protein<br>Content | ASTM D5712<br>N=3<br>Less than 200 µg/dm² | Less than 200 µg/dm² | | | Protein Content (µg/dm²) | | | | | Similar | | |
| | | | | | Size | | Actual value | | | | | |
| | | | | | Small | | 124.36 | | | | | |
| | | | | | Medium | | 140.78 | | | | | |
| | | | | | Large | | 134.26 | | | | | |
| | | | | | Extra Large | | 159.46 | | | | | |
| Cytotoxicity | ISO 10993-11<br>The test article showed<br>"negative" systemic<br>toxicity | | | | Under the conditions of the study, the test<br>article showed "negative" systemic toxicity. | Non-cytotoxic | | | | | SAME | |
| Irritation | ISO 10993-23<br>The response of the test<br>article has no skin<br>irritation | | | | Under the experimental conditions, the test<br>article has no skin irritation on rabbits. | Non-irritating | | | | | SAME | |
| Sensitization | ISO 10993-10<br>The test article showed<br>no evidence of causing<br>delayed dermal contact<br>sensitization. | | | | The test article showed no evidence of causing<br>delayed dermal contact sensitization in the<br>guinea pig. | Non-sensitizing | | | | | SAME | |

# 9. Summary of Non-Clinical Testing

Bench tests were conducted to demonstrate that the proposed device complies with the following standards:

ISO 10993-10: 2021 Biological Evaluation Of Medical Devices - Part 10: Tests For Skin Sensitization.

ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ASTM D3578-19 Standard Specification for Rubber Examination Gloves

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| Test Item | Test Method | Test Purpose/Description | Acceptance Criteria | Results |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acute<br>Systemic<br>Toxicity<br>Test | Extraction Method | The test was designed to<br>evaluate the potential acute<br>system toxicity caused by<br>test article contact with the<br>ICR<br>mice<br>and<br>extrapolating the results to<br>humans. | ISO 10993-11<br>Biological evaluation of<br>medical devices - Part<br>11: Tests for systemic<br>toxicity. | The test article<br>has no potential<br>acute system<br>toxicity on ICR<br>mice in the<br>extraction<br>method. |
| Skin<br>Irritation<br>Test | Extraction Method | To evaluate the potential<br>skin irritation caused by<br>test article contact with the<br>skin surface of rabbits and<br>extrapolating the results to<br>humans, but it does not<br>establish the actual risk of<br>irritation. | ISO 10993-23: 2021<br>Biological evaluation of<br>medical devices - Part<br>23: Tests for irritation. | Under the<br>experimental<br>conditions, the<br>test article has<br>no skin<br>irritation on<br>rabbits. |
| Skin<br>Sensitization<br>Test | Guinea<br>Pig<br>Maximization | The test was designed to<br>evaluate the potential of a<br>test article to cause skin<br>sensitization. The test is<br>used as a procedure for<br>screening of contact<br>allergens in guinea pigs<br>and extrapolating the<br>results to humans, but it<br>does not establish the<br>actual risk of sensitization. | ISO 10993-10: 2021<br>Biological Evaluation<br>Of Medical Devices -<br>Part 10: Tests For Skin<br>Sensitization. | Under the<br>experimental<br>conditions, the<br>test article has<br>no potential<br>skin<br>sensitization on<br>guinea pigs in<br>the method. |
| Physical<br>Dimensions<br>Test | Use steel ruler and<br>the apparatus for<br>measurement of<br>thickness (0-10mm)<br>to measure gloves<br>Physical dimensions. | The gloves shall comply<br>with the dimension<br>requirements prescribed in<br>ASTM D3578-19 Table 2. | Inspection Level: S-2<br>AQL: 4.0 | The subject<br>device comply<br>with the<br>dimension<br>requirements<br>prescribed in<br>ASTM D3578-<br>19. |
| Physical<br>Property<br>Characteristics Test | Dumbbell and<br>Straight Section<br>Specimens. | Before and<br>after accelerated aging, the<br>gloves shall conform to the<br>physical requirements<br>specified in ASTM<br>D3578-19 Table 3. | Inspection Level:<br>AQL: | Before and after<br>accelerated<br>aging, the<br>subject device<br>conform to the<br>physical<br>requirements<br>specified in<br>ASTM D3578-<br>19 Table 3. |
| Freedom<br>From Holes<br>Test | Refer to the ASTM<br>D 5151-06, Standard<br>Test Method for<br>Detection of Holes in<br>Medical Gloves. | This test method is to the<br>detection of holes that<br>allow water leakage under<br>the conditions of the test. | Inspection Level: I<br>AQL: 2.5 | No water<br>leakage is<br>inspected.<br>The subject<br>device conform<br>to the<br>requirements<br>specified in<br>ASTM D5151. |
| Powdered<br>Glove Test | Refer to the ASTM<br>D 6124-06, R2017,<br>Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves. | These test are the<br>determination of average<br>powder or filter-retained<br>mass found on a sample of<br>medical gloves as<br>described in the<br>introduction. | Inspection Level: N=5<br>Residual Powder less<br>than 2 mg per glove. | Residual<br>Powder less<br>than 2 mg per<br>glove.<br>The subject<br>device conform<br>to the<br>requirements<br>specified in<br>ASTM D6124. |
| Extractable<br>Protein Test | Refer to the ASTM<br>D5712 Standard Test<br>Method for Analysis<br>of Aqueous<br>Extractable Protein<br>in Latex, Natural<br>Rubber, and<br>Elastomeric Products<br>Using the Modified<br>Lowry Method. | The test was designed to<br>test the laechable protein<br>of the test glove. | Inspection Level: N=3<br>Less than 200 µg/dm². | The results<br>showed that the<br>average<br>Extractable<br>Protein of test<br>samples was<br>met the<br>acceptance<br>criteria in<br>ASTM D5712. |

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- 10. Summary of Clinical Testing Not applicable
- 11. Conclusions

Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, BEST GLOVE -LATEX POWDER FREE EXAMINATION GLOVE, cleared under K210253.