Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue

K153028 · Zibo Huiying Medical Products, Co. , Ltd. · LYZ · Feb 5, 2016 · General Hospital

Device Facts

• Record ID: K153028
• Device Name: Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue
• Applicant: Zibo Huiying Medical Products, Co. , Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Feb 5, 2016
• 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 or fingers to prevent contamination between patient and examiner.

Device Story

Synmax Synthetic Patient Examination Vinyl Gloves are disposable, non-sterile, powder-free blue gloves; intended for use by healthcare examiners to prevent cross-contamination between patient and examiner. Device covers hand and wrist area; provides barrier protection during medical examinations. Manufactured from Poly Vinyl Chloride, Polyurethane, and Diisononyl Phthalate (DINP). Used in clinical settings; operated by physicians, nurses, or technicians. Output is physical barrier protection; clinical decision-making unaffected; benefits patient by reducing risk of infection transmission during contact.

Clinical Evidence

No clinical data. Bench testing only. Testing included physical dimensions, tensile strength/elongation (before and after aging), water fill test (ASTM D5151-06) for pinholes (AQL 2.5), residual powder content (ASTM D6124-06, <2mg/glove), and biocompatibility (ISO 10993-10 for skin irritation and sensitization).

Technological Characteristics

Materials: Poly Vinyl Chloride, Polyurethane, Diisononyl Phthalate (DINP). Non-sterile. Powder-free. Dimensions: ~234mm length, 96mm palm width. Thickness: 0.096mm palm, 0.98mm finger. Standards: ASTM D5250-06, ASTM D5151-06, ASTM D6124-06, ISO 10993-10. No software or electronic components.

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. Suitable for surface-contacting use with less than 24 hours duration.

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

• Grand Work Plastic Products Co., Ltd. Vinyl Nitrile Co-Polymer Powder Free Exam Blue Gloves (K051662)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 5, 2016

Zibo Huiying Medical Products, Co. Ltd. % Sophie Hao Official Correspondent Basic Medical Industries, Inc. 12390 East End Ave Chino, California 91710

Re: K153028

Trade/Device Name: Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 18, 2015 Received: December 18, 2015

Dear Sophie Hao:

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. 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 statutes and regulations administered by other Federal agencies. You must comply

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

#### 510(k) Number (if known) K153028

#### Device Name

Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue

Indications for Use (Describe)

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

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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# 510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.

### 1. Submitter's Identification:

Zibo Huiying Medical Products, Co. Ltd. No. 3, Da Wu Road Linzi, Shandong China Tel: [phone]

## Contact Person

Sophie Hao Tel: [phone], Fax: [phone] [e-mail]

Date summary prepared: Jan 7, 2016

- 2. Name of the Device: Synmax Synthetic Patient Examination Vinyl Gloves. Powder Free, Blue
- 3. Common Name: Patient Examination Gloves

## 4. Predicate Device Information: Grand Work Plastic Products Co., Ltd. Vinyl Nitrile Co-Polymer Powder Free Exam Blue Gloves (K051662)

## 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, LYZ, and meets all requirements of ASTM D5250-06.

- 6. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.(21 CFR 880.6250)

## 7. Comparison to Predicate Devices on Indication for Use:

Zibo Huiying Medical Products, Co. Ltd. Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue is substantially equivalent in safety, and effectiveness to Grand Work Plastics Product Vinyl Nitrile Co-Polymer Powder Free Exam Blue Glove (K051662).

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## 8. Discussion of Non-Clinical Test Performed for Determination of Substantial Equivalence are as Follows:

The standards used for Zibo Huiying Medical Products, Co. Ltd.'s gloves product are based on ASTM D-5250. All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AOL 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 (allergic contact dermatitis) testing was conducted in accordance with ISO 10993-10 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Sensitization with results showing no primary skin irritation or sensitization reactions under the conditions tested.

There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.

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

## 9. Patient Contact

The glove is available for surface-contacting with less than 24 hours duration.

## 10. Sterilization

The subject device is non-sterile.

## l 1. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim.

## 12. Device Comparison Table

Please see below for detailed updated comparison between our device and predicate device.

## 13. Conclusions:

The Synmax Synthetic Patient Examination Vinyl Glove, Powder Free (Blue) is substantially equivalent to the Grand Works Plastics Vinyl Nitrile Co-Polymer Powder Free Exam Gloves (Blue). Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, Grand Works Plastics Vinyl Nitrile Co-Polymer Powder Free Exam Gloves (Blue) cleared under K051662.

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## Table. Side-by-Side Comparison of Intended Use, Design, Material, Physical, Biocompatibility, and Performance Testing

| | Proposed Device | Predicate Device (K051662) |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | Zibo Huiying Medical Products, Co.<br>Ltd. Synmax Synthetic Examination<br>Vinyl Gloves, Powder Free, Blue | Grand Work Plastics Product<br>Vinyl Nitrile Co-Polymer<br>Powder Free Exam Blue<br>Gloves |
| Indication for use | Cover the hand and wrist area. It is a<br>disposable device which is worn upon<br>the examiner's hands or fingers to<br>prevent contamination between patient<br>and examiner. | Cover the hand and wrist area.<br>It is a disposable device which<br>is worn upon the examiner's<br>hands or fingers to prevent<br>contamination between patient<br>and examiner. |
| Labeling: Labels on<br>the carton | Labels include: Product name; color;<br>"single use Only" size, piece count, lot<br>number, distributor name, and<br>manufacturer address. | Labels include: Product name;<br>color; "single use Only" size,<br>piece count, lot number,<br>distributor name, and<br>manufacturer address. |
| Device Materials | Poly Vinyl Chloride<br>Polyurethane<br>Diisononyl Phthalate (DINP) | Poly Vinyl Chloride<br>Nitrile<br>Polyurethane<br>Diisononyl Phthalate (DINP) |
| Before Aging:<br>Tensile<br>Strength(Mpa) and<br>Ultimate<br>Elongations | Average Tensile Strength (Mpa): 16.9<br>Average Ultimate Elongations: 550% | Substantially Equivalent<br>Conforms to ASTM D5250 and<br>ASTM D6319 -00al.<br>Tensile Strength: 16 mpa min<br>Elongation: 500 % min |
| After Aging: Tensile<br>Strength(Mpa) and<br>Ultimate<br>Elongations | Average Tensile Strength (Mpa): 14.4<br>Average Ultimate Elongations: 500% | Substantially equivalent<br>Conforms to ASTM D5250 and<br>ASTM D6319 -00al.<br>Tensile Strength: 14 mpa min,<br>Elongation: 400 % min |
| Overall Length on<br>Medium Size | Average over 234mm | Substantially equivalent<br>Conforms to ASTM D5250 and<br>ASTM D6319 -00al.<br>230 min |
| Width of Palm on<br>Medium Size | Average 96mm | Substantially equivalent<br>Conforms to ASTM D5250 and<br>ASTM D6319 -00al.<br>95 ± 10 mm |
| Palm Thickness | Average 0.096 mm | Substantially equivalent<br>Conforms to ASTM D5250 and<br>ASTM D6319 -00al.<br>0.05 mm min. |
| Finger Thickness | Average 0.98 mm | Substantially equivalent<br>Conforms to ASTM D5250 and<br>ASTM D6319 -00al.<br>0.05 mm min |
| Residual Powder | According to ASTM D6124-06<br>Standard Test Method for Residual<br>Powder on Medical gloves for the<br>determination of residual powder<br>content. 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 there<br>is no defect glove found according to<br>ASTM D6124-06. | Substantially equivalent<br>Conforms to ASTMD6124-06<br>The weight of all types of<br>residual or powder on finished<br>powder-free gloves as < 2 mg<br>per glove and there is no defect<br>glove found |
| Pinhole Results | According to ASTM D5151-06,<br>Testing result indicates pinhole were<br>found less than two pieces gloves out<br>of 125 pieces gloves. AQL 2.5 is met. | Substantially equivalent<br>Conforms to ASTM D5151-06<br>AQL 2.5 |
| Biocompatibility<br>Result: Primary Skin<br>Irritation | Under the conditions tested, the<br>subject device was not an irritant | Substantially equivalent<br>The subject device was not an<br>irritant |
| Dermal Sensitization | Under the conditions tested, the<br>subject device was not a sensitizer | Substantially equivalent<br>The subject device was not a<br>sensitizer |
| Summary of<br>comparison | The Synmax Synthetic Patient Examination Vinyl Glove, Powder Free<br>(Blue) is substantially equivalent to the Grand Works Plastics Vinyl<br>Nitrile Co-Polymer Powder Free Exam Gloves (Blue). Based on the<br>nonclinical tests performed, the subject device is as safe, as effective,<br>and performs as well as the legally marketed predicate device, Grand<br>Works Plastics Vinyl Nitrile Co-Polymer Powder Free Exam Gloves<br>(Blue) cleared under K051662. | |

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