Powder-Free Vinyl Patient Examination Gloves, Yellow Color

K191092 · Anhui Intco Medical Products Co., Ltd. · LYZ · Jul 22, 2019 · General Hospital

Device Facts

• Record ID: K191092
• Device Name: Powder-Free Vinyl Patient Examination Gloves, Yellow Color
• Applicant: Anhui Intco Medical Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

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

Device Story

Disposable vinyl patient examination gloves; worn on hands/fingers by medical examiners; prevents cross-contamination between patients and examiners. Device is a physical barrier; no electronic or software components. Used in clinical settings.

Clinical Evidence

No clinical data. Bench testing only. Testing included physical dimensions, tensile strength, ultimate elongation (before and after aging), pinhole leak testing (ASTM D5151-06), residual powder content (ASTM D6124-06), and biocompatibility (primary skin irritation and sensitization).

Technological Characteristics

Material: Poly Vinyl Chloride (PVC). Form factor: Powder-free patient examination glove, yellow color. Standards: ASTM D-6319, ASTM D-5250, ASTM D-5151-06, ASTM D-6124-06. Non-sterile. No energy source or software.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between patients and examiners.

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 Gloves, Powder-Free, Yellow (K022091)

Submission Summary (Full Text)

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July 22, 2019

Anhui Intco Medical Products Co. Ltd % Derek Tian Official Correspondent Intco Medical Industries, Inc. 805 Barrington Ave Ontario. California 91764

Re: K191092

Trade/Device Name: Powder-Free Vinyl Patient Examination Gloves, Yellow Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: April 16, 2019 Received: April 24, 2019

Dear Derek Tian:

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 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 Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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)

## K191092

Device Name

Powder-free vinyl patient examination gloves, Yellow Color

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# Anhui Intco Medical Products Co,ltd

No. 1 Haitang Road, Suixi District economic development area, Huaibei City, Anhui Province

# 510(K) SUMMARY

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

# 1. Submitter's Identification:

Anhui Intco Medical Products Co, Itd. No.1 Haitang Road, Suixi District economic development area Huaibei City, Anhui Province China

## Contact Person

Jacken Cai Tel: [phone]

Date summary prepared: July 17, 2019

#### 2. Name of the Device: Powder-free Vinyl Patient Examination Gloves, Yellow Color

#### 3. Common Name:

Non-powdered patient examination glove

# 4. Predicate Device Information:

Device name: Vinyl Examination Gloves, Powder-Free, Yellow 510(K) #: K022091 Manufacturer name: Tangshan Zhonghong Pulin Food Products Co., Ltd

# 5. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D-6139 and ASTM D-5250.

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# 6. Intended Use:

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

| | Subject Device<br>(K191092) | Predicate Device<br>(K022091) | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Description | Powder-free Vinyl Patient<br>Examination Gloves, Yellow<br>Color by Anhui Intco Medical<br>Products Co, ltd. | Vinyl Examination Gloves,<br>Powder-Free, Yellow by<br>Tangshan Zhonghong Pulin<br>Food Products Co.,<br>Ltd. | Similar |
| Indication for use | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn upon the examiners'<br>hands or fingers to prevent<br>contamination between patients<br>and examiners. | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn upon the examiners'<br>hands or fingers to prevent<br>contamination between<br>patients and<br>examiners. | Same |
| Labeling: Labels<br>on the carton | Labels include: Product name;<br>color; "single use Only" size,<br>piece count, lot number,<br>distributor <b>name</b> , and<br>manufacturer address. | Labels include: Product<br>name; color; "single use Only"<br>size, piece count, lot number,<br>distributor name, and<br>manufacturer address. | Same |
| Device Materials | Poly Vinyl Chloride | Poly Vinyl Chloride | Same |
| Before Aging:<br>Tensile<br>Strength(Mpa) and<br>Ultimate<br>Elongations | Average Tensile<br>Strength (Mpa): 17.44<br>Average Ultimate Elongations:<br>519.4% | Average Tensile<br>Strength (Mpa): 17.00<br>Average Ultimate<br>Elongations: 500% | Similar |
| After Aging:<br>Tensile<br>Strength(Mpa) and<br>Ultimate<br>Elongations | Average Tensile<br>Strength (Mpa): 15<br>Average Ultimate Elongations:<br>481.96% | Average Tensile<br>Strength (Mpa): 15 Average<br>Ultimate<br>Elongations: 475% | Similar |
| Overall Length on<br>Medium Size | Average over 232.23mm | Average over 230.00 mm | Similar |
| Width of Palm on<br>Medium Size | Average 95.08mm | Average 95.00mm | Same |
| Palm Thickness | Average 0.095 mm | Average 0.095 mm | Same |
| Figure Thickness | Average 0.090 mm | Average 0.090 mm | Similar |
| Residual Powder | According to ASTM D6124-06<br>Standard Test Method for<br>Residual Powder on Medical<br>gloves for the determination of<br> | According to ASTM D6124-06<br>Standard Test Method for<br>Residual Powder on Medical<br>gloves for the determination of<br>residual powder content.<br>Testing result indicates the<br>weight of all types of residual or<br>powder on finished powder-free<br>gloves as < 2 mg per glove and<br>there is no defect glove found<br>according to ASTM D6124-06. | Same |
| Pinhole Results | According to ASTM D5151-06, Testing result indicates pinhole were found less than two pieces gloves out of 125 pieces gloves. AQL 2.5 is met. | According to ASTM D5151-06, Testing result indicates pinhole were found less than two pieces gloves out of 125 pieces gloves. AQL 2.5 is met. | Same |
| Biocompatibility | | | |
| Primary<br>Skin Irritation | Based on the conditions of the test the animal model did not demonstrate an irritation response from both device extract. Therefore, the device is not an irritant | Based on the conditions of the test the animal model did not demonstrate an irritation response from both device extract. Therefore, the device is not an irritant | Same |
| Dermal<br>Sensitization | Based on the conditions of the test the animal model did not demonstrate a sensitization response from both device extract. Therefore, the device is not a sensitizer | Based on the conditions of the test the animal model did not demonstrate a sensitization response from both device extract. Therefore, the device is not a sensitizer | Same |
| Cytotoxicity | | | |
| Based on the conditions of the<br>test assay did not demonstrate<br>any significant cell lysis from<br>the device extract. Therefore,<br>the device is not cytotoxic | / | | |

# 7. Technological Characteristics

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## 8. Summarv of Non-Clinical Testing:

The standards used for Anhui Intco Medical Products Co, Itd.'s gloves product are based on ASTM D-6319 and ASTM D-5250. All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 2.5.

The FDA 1000 ml Water Fill Test based on ASTM-D5151-06 was also conducted samplings of AQL 2.5 inspection level G-1. meeting these requirements. Primary Skin Irritation and Skin Sensitization testing was conducted with results showing no primary skin irritant or sensitization reactions.

A Residual Powder Test that based on ASTM D-6124 for start to finish inspection is conducted to ensure that our gloves meet our "powder-free" claims (contains no more than 2 mg powder per glove).

# 9. Summary of Clinical Tests Performed:

Not Applicable

# 10. Conclusions:

Based on the Indication for Use, technological characteristics, and non-clinical performance data, Powder-free Vinyl Patient Examination Gloves, Yellow Color (K191092, 510(K) number) is as safe, as effective, and perform as well as or better than the legally marketed predicate devices, Vinyl Examination Gloves, Powder-Free, Yellow (K022091)