Disposable Synthetic Examination Gloves

K210520 · Shandong Shengshixincheng Medical Science & Technology Co., · LYZ · May 26, 2021 · General Hospital

Device Facts

• Record ID: K210520
• Device Name: Disposable Synthetic Examination Gloves
• Applicant: Shandong Shengshixincheng Medical Science & Technology Co.,
• Product Code: LYZ · General Hospital
• Decision Date: May 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Disposable, non-sterile, blue, powder-free synthetic examination gloves; made of poly vinyl chloride, polyurethane, and DOTP. Used in clinical settings by healthcare providers to prevent cross-contamination between patient and examiner. Device is ambidextrous and available in sizes S, M, L, and XL. Performance verified against ASTM standards for physical dimensions, tensile strength, elongation, and freedom from holes. Biocompatibility confirmed via ISO 10993 testing for irritation, sensitization, and cytotoxicity. Provides a barrier protection benefit to both patient and clinician.

Clinical Evidence

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

Technological Characteristics

Materials: Poly vinyl chloride, polyurethane, DOTP. Non-sterile. Ambidextrous. Powder-free. Complies with ASTM D6124, ASTM D5151, ASTM D5250, ISO 10993-5, and ISO 10993-10. Dimensions: 230mm length; 85-115mm width depending on size; 0.08mm min thickness.

Indications for Use

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

• Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue (K153028)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.

May 26, 2021

Shandong Shengshixincheng Medical Science & Technology Co., % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K210520

Trade/Device Name: Disposable Synthetic Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: April 15, 2021 Received: April 19, 2021

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

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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 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 Ryan Ortega 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) K210520

Device Name Disposable Synthetic Examination Gloves

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon 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 (K210520)

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

# 1.0 Submitter's Information

Shandong Shengshixincheng Medical Science & Technology Co., Ltd. Name: Address: No.28 Aluminum Deep Processing Industrial Park, Changshan Town,Zouping, Binzhou,Shandong Province, China. Phone Number: [phone] Contact: Ping Wang Date of Preparation: 04/15/2021

# Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: [phone] Email: [e-mail]

# 2.0 Device Information

Trade name: Disposable Synthetic Examination Gloves Vinyl Patient Examination Glove Common name: 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: Zibo Huiying Medical Products, Co. Ltd. Device: Synmax Synthetic Patient Examination Vinyl Gloves,Powder Free,Blue 510(k) number: K153028

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# 5.0 Indication for Use

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

## 6.0 Device Description

The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

# 7.0 Technological Characteristic Comparison Table

| Item | Subject device | Predicated device | Comparison |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) number | K210520 | K153028 | / |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that is<br>worn upon the<br>examiner's hands to<br>prevent contamination<br>between patient and<br>examiner. | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that<br>is worn upon the<br>examiner's hands or<br>fingers to prevent<br>contamination between<br>patient and examiner. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Labeling Information | Single use, powder free,<br>device color, device<br>name, glove size and<br>quantity, product name,<br>Non-Sterile | Single use, powder<br>free, device color,<br>device name, glove<br>size and quantity,<br>product name, Non-<br>Sterile | Similar |

#### Table1-General Comparison

# Table2 Device Dimensions Comparison

| Predicate<br>Device(K153028) | Designation | Size | Tolerance |
|------------------------------|-------------|----------------------------|-----------|
| | Length, mm | Average over 234 on M size | - |

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| | Width, mm | Average over 96 on M size | | | | |
|-----------------|----------------|---------------------------|-----|-----------|-----|-----|
| | Thickness, mm: | | | | | |
| | Finger | Average 0.098 | | - | | |
| | Palm | Average 0.096 | | - | | |
| Subject | Designation | Size | | Tolerance | | |
| Device(K210520) | | S | M | L | XL | |
| | Length, mm | 230 | 230 | 230 | 230 | min |
| | Width, mm | 85 | 95 | 105 | 115 | ±5 |
| | Thickness, mm: | | | | | |
| | Finger | 0.08 | | min | | |
| | Palm | 0.08 | | min | | |
| Remark | | Similar | | | | |

Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250,so the differences do not raise any new safety or performance questions.

| Item | | Subject device<br>(K210520) | Predicated device<br>(K153028) | Comparison | |
|------------------------|-----------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------|----------|
| Colorant | | Blue | Blue | Same | |
| Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | 11MPa, min | Average 16.9MPa | Analysis |
| | | Ultimate<br>Elongation | 300%min | Average 550% | Analysis |
| | After<br>Aging | Tensile<br>Strength | 11MPa, min | Average 14.4MPa, min | Analysis |
| | | Ultimate<br>Elongation | 300%min | Average 500% | Analysis |
| | | Comply with ASTM D5250 | | Same | |
| Freedom from Holes | | Be free from holes when<br>tested in<br>accordance with<br>ASTM D5151<br>AQL=2.5 | Be free from holes when<br>tested in accordance with<br>ASTM D5151 AQL=2.5 | Same | |
| Powder Content | | 0.01 mg per glove,<br>Meet the<br>requirements of<br>ASTM D6124 | Meet the requirements of<br>ASTM D6124 | Similar | |

#### Table3 Performance Comparison

Analysis: 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 any new safety or performance questions.

# Table4 Safety Comparison

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| Item | | Subject device<br>(K210520) | Predicated device<br>(K153028) | Comparison |
|--------------------|---------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------|
| Material | | Poly Vinyl Chloride<br>Polyurethane<br>Nitrile<br>Di-(2-ethylhexyl)<br>Terephthalate(DOTP) | Poly Vinyl Chloride<br>Polyurethane<br>Diisononyl Phthalate<br>(DINP) | Similar |
| Biocompatibility | Irritation | Under the conditions of the<br>study, not an irritant | Comply with<br>ISO10993-10 | SAME |
| | Sensitization | Under conditions of the<br>study, not a sensitizer. | | |
| | Cytotoxicity | Under conditions of the<br>study, did not show potential<br>toxicity to L-929 cells. | / | Different |
| Label and Labeling | | Meet FDA's Requirement | Meet FDA'S Requirement | SAME |

Analysis: The materials of the subject device are little different with that of the predicate, but they all meet the performance requirements of ASTM D5250,also biocompatibility test has been performed on subject device and the test result can meet the requirements of ISO 10993 standards. Therefore, the differences will not raise any safety and effectiveness issues on performance and biocompatibility.

# 8.0 Discussion of Non-clinical and Clinical Test Performed

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 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves

ASTMD5151-19, Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

# 9.0 Clinical Test Conclusion

Clinical testing is not needed for this device.

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#### 10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K153028.