MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)

K123126 · Shanghai Motex Healthcare Co., Ltd. · KGO · Jun 4, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K123126
• Device Name: MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)
• Applicant: Shanghai Motex Healthcare Co., Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jun 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

Device Story

Sterile, single-use surgical gloves made of synthetic polyisoprene rubber; intended for use by operating room personnel to protect surgical wounds from contamination. Available in two thicknesses (Model 6412 thin, 6512 thick) and two colors (Nature, Blue). Features include curved fingers, textured surface, and beaded cuff. Sterilized via radiation. Protects patient and user from cross-contamination; non-latex material prevents latex-related allergic reactions.

Clinical Evidence

Bench testing only. Compliance with ASTM D3577-09 (dimensions, physical properties, freedom from holes), ASTM D6124-06 (residual powder), ASTM D5151-06 (water leak), and ASTM D5712-10 (protein content). Biocompatibility testing per ISO 10993-10 and ISO 10993-12 confirmed non-irritant and non-sensitizing properties. Sterilization validated per ISO 11137-1 and ISO 11137-2.

Technological Characteristics

Material: Synthetic polyisoprene. Form factor: Curved finger, textured surface, beaded cuff. Sterilization: Radiation (ISO 11137). Standards: ASTM D3577-09, ASTM D6124-06, ASTM D5151-06, ASTM D5712-10. Biocompatibility: ISO 10993. Single-use, non-latex.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. For use as a sterile, powder-free, synthetic rubber surgeon's glove.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves (K093300)

Submission Summary (Full Text)

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## SHANGHAI MOTEX HEATHCARE CO., LTD.

No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: [phone] Fax: [phone]

## II. 510(K) Summary of Safety and Effectiveness (Per 21 CFR 807.92)

## JUN 0 4 2014

### 2.1. General Information Establishment

- Manufacturer: Shanghai Motex Healthcare Co., Ltd.
- 특 Address: No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China

K123126

- 그 Owner Number: 9041164 Registration Number: 9615978
- 를 Contact Person: Dr. Jen, Ke-Min E-mail: [e-mail] Tel: [phone] : Fax: [phone]
- 그 May 23, 2014 . Date Prepared:

Proprietary Name:

### Subject Device:

- MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Nature MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Blue MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Nature MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Blue

| • Common Name: | Surgeon's glove |
|----------------|-----------------|
|----------------|-----------------|

- . Classification Name: Surgeon's Gloves
- Product Code: KGO, Class I
- Regulation Number: 878.4460
- Predicate device:
- . Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves (K093300)

### 2.2. Safety and Effectiveness Information

- Predicate Device:
Claim of Substantial Equivalence (SE) is made to Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves (K093300)

- Device Description:
Motex Powder-free Polyisoprene Surgical Sterile Gloves, Model # 6412 Nature, 6412_Blue; 6512_Nature, 6512_Blue are made of synthetic rubber. The sterile gloves are sterilized by the radiation method. 6412 Nature, 6412 Blue are of thin gloves. 6512 Nature, 6512 Blue are of thick gloves. They are processed by special treatment with no protein, and intended to be used in surgery to prevent the cross contamination between patients and users.

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No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: [phone] Fax: [phone]

### Motex Polyisoprene Powder-free Surgical Gloves variant models

| Model | Size | Product Description | | | | | Size | |
|-------|-------------------------------------|---------------------|----------|-------------|---------|-------------|--------------|------------------|
| | | Hand shape | Surface | Beaded cuff | Sterile | Color | Length (min) | Thickness (min) |
| 6412 | 6, 6.5, 7, 7.5, 8, 8.5<br>(Sterile) | Curved Finger | Textured | • | • | Nature Blue | $280\pm6$ mm | $0.13\pm0.03$ mm |
| 6512 | 6, 6.5, 7, 7.5, 8, 8.5<br>(Sterile) | Curved Finger | Textured | • | • | Nature Blue | $280\pm6$ mm | $0.15\pm0.03$ mm |

#### ● Indications for Use:

MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

#### . Device Characteristics:

a. Single use only.

b. Not made with natural rubber latex.

#### ● Powder Residual:

Surgeon's gloves meet powder level requirements for Powder-free" designation per ASTM D6124-06 (Reaffirmation 2011), Standard test method for residual powder on medical gloves.

The results generated values will be below 2mg of residual powder per glove.

#### ● Biocompatibility Test Reports:

There are complied with the biological evaluation and the results of these studies show that the MOTEX Polyisoprene Powder-free Sterile Surgical Glove safety for its intended use, including:

- � Systemic Intravenous Injection
- Systemic Intraperitoneal Injection
- Skin Sensitization Test (Maximization test), Sesame oil extract;
- . Sensitization Test (Maximization test), Sodium Chloride extract;
- Skin Irritation Test, Sesame oil extract;
- Skin Irritation Test, Sodium Chloride extract;

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No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: [phone] Fax: [phone]

- Clinical Data:
Not applicable.

#### Comparison between the subject devices and the predicate device ●

| Feature | Predicate device | Subject device |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary name | Esteem SMT Polyisoprene<br>Powder-Free Surgical Sterile<br>Gloves | Motex Powder-free Polyisoprene<br>Surgical Gloves |
| 510(k) number | K093300 | K123126 |
| Model | SMT | 6412 (nature, blue)<br>6512 (nature, blue) |
| Indications For Use | Powder-Free Polyisoprene Surgical<br>Gloves are sterile disposable<br>devices made of imported synthetic<br>rubber intended to be worn by<br>operating room personnel to<br>protect a surgical wound from<br>contamination in the environments<br>within hospitals and other<br>healthcare facilities. | MOTEX Polyisoprene Powder-Free<br>Sterile Surgical Gloves are<br>powder-free surgeon's glove made of<br>synthetic rubber intended to be worn<br>by operating room personnel to<br>protect a surgical wound from<br>contamination. The lubricating or<br>dusting powder used in the glove is<br>excluded. |
| Prescription/OTC<br>Device | Over-the-Counter Use | Over-the-Counter Use |
| Product code | KGO | KGO |
| Classification | Class I | Class I |
| Regulation number | 878.4460 | 878.4460 |
| Manufacturing<br>material | Synthetic Polyisoprene | Synthetic Polyisoprene |
| Specifications | | |
| Size | N/A | Size: 6, 6.5, 7, 7.5, 8, 8.5 |
| Length (mm) | N/A | $280\pm6$ |
| Width (mm) | N/A | size 6--77, size 6.5--84,<br>size 7--91, size 7.5--98,<br>size 8--102, size 8.5-108 |
| Thickness (finger,<br>palm, cuff) (mm) | N/A | (6412)—<br>$0.13\pm0.03$ ,<br>$0.13\pm0.03$<br>(6512)—<br>$0.15\pm0.03$ ,<br>$0.15\pm0.03$ |
| Tensile strength<br>(before and after<br>aging), | N/A | Before aging: 24 Mpa<br>After aging: 23 Mpa |
| ultimate elongation<br>(%) (before and after<br>aging) | N/A | Before aging : 929%<br>After aging : 879% |
| Test for Pinhole,<br>Dimensions, and<br>Physical properties | Meets ASTM D3577-09 | Meets ASTM D3577-09 |
| Residual powder<br>testing | Meets ASTM D 6124-06<br>Residual powder < 2mg | Meets ASTM D6124-06<br>(Reaffirmation 2011)<br>Residual powder < 2mg |
| Water leak<br>testing(AQL) | Meets ASTM D 5151-06<br>(AQL=1.5) | Meets ASTM D 5151-06<br>(Reapproved 2011)<br>(AQL=1.5) |
| Water extractable<br>protein testing | Meets ASTM D 5712-10<br>No protein content | Meets ASTM D 5712-10<br>No protein content |
| Biocompatibility | non irritant<br>non sensitizing | non irritant<br>non sensitizing |
| Sterilization Validation | Pass ISO11137-1<br>ISO11137-2<br>Sterilization Assurance Number:<br>1 x 10-6 | Pass ISO11137-1:2006<br>(Amendment 1:2013)<br>ISO11137-2:2013<br>Sterilization Assurance Number:<br>1 x 10-6 |

## Comparison Table

K 123 126

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## SHANGHAI MOTEX HEALTHCARE CO., LTD.

No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: [phone] Fax: [phone]

#### ● Discussion of the similarities

The same performance data of the Motex Powder-free Polyisoprene Sterile Surgical Gloves compared to the predicate device are summarized below.

| Characteristics | Standard |
|-----------------------------------|-------------------------------------------------------------------------|
| Dimensions | meets ASTM D 3577-09, |
| Physical Properties | meets ASTM D 3577-09, |
| Freedom from Holes | meets ASTM D 3577-09, |
| Residual powder testing | meets ASTM D 6124-06 (Reaffirmation 2011) |
| Water leak testing | meets ASTM D 5151-06 (Reapproved 2011) |
| Water extractable protein testing | meets ASTM D 5712-10 |
| Biocompatibility | non irritant & non- sensitizing<br>ISO10993-10:2010<br>ISO10993-12:2012 |
| Sterilization Validation | Pass ISO11137-1:2006 (Amendment 1:2013)<br>ISO11137-2:2013 |

K 123 126

4

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The subject device and the predicate device have the similar indications for use, the same material composition with Polyisoprene, the same technological characteristics, and the same biocompatibility and sterilization validation testing. There are no safety or effectiveness aspects raising.

#### ● Discussion of the differences

The minor differences between them are thickness and size. Both of them meet ASTM D 3577-09, ASTM D 6124-06 (Reaffirmation 2011), ASTM D 5151-06 (Reapproved 2011), ASTM D 5712-10, and biocompatibility testing. The safety or effectiveness aspects are not raised.

#### ● Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in the submission.

> Dr. Jen, Ke-Min 510(k) correspondent person for Shanghai Motex Healthcare Co., Ltd.

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

## JUL 18 2014

Shanghai Motex Healthcare Co., Ltd Dr. Jen, Ke-Min No. 369 Jiasong Zhong Road, Huaxin, Qingpu Shanghai 201708 CHINA

Re: K123126

Trade/Device Names: MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Nature: MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Blue; MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Nature: MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Blue

Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: April 26, 2014 Received: May 5, 2014

Dear Dr. Jen, Ke-Min:

This letter corrects our substantially equivalent letter of June 4, 2014.

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.

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Page 2 - Dr. Jen, Ke-Min

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 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 device-related 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" (21CFR 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,

# Mary S. Runner -S

Erin I. Keith, M.S. 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|-----------------------------------|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement below |

| 510(k) Number (if known) | K123126 |
|--------------------------|---------------------------------------------------------------------------|
| Device Name | MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Nature |
| | MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Blue |
| | MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Nature |
| | MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Blue |

| Indications for Use (Describe) | MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Type of Use (Select one or both, as applicable) | <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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FOR FDA USE ONLY

| Concurrence of Center for Devices and Radiological Health | Elizabeth F. Claverie |
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