ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA

K103714 · Ansell Healthcare Products, LLC · KGO · Jul 7, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K103714
• Device Name: ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA
• Applicant: Ansell Healthcare Products, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jul 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has been tested for use with chemotherapy drugs.

Device Story

Disposable natural latex rubber surgical gloves; worn by operating room personnel to protect surgical wounds from contamination. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Provides barrier protection during surgical procedures. Output is physical barrier; healthcare providers use gloves to maintain sterile field and protect against chemical exposure. Benefits include reduced risk of surgical site contamination and protection of personnel from hazardous chemotherapy agents.

Clinical Evidence

No clinical data. Bench testing only. Device performance verified against ASTM D3577-09e1 (dimensions, physical properties), ASTM D5151-06 (freedom from holes), ASTM D6124-06 (powder-free), and ASTM D5712 (protein content). Chemotherapy drug permeation tested per ASTM D6978-05.

Technological Characteristics

Natural latex rubber; powder-free (≤ 2 mg/glove); extractable protein content ≤ 50 μg/dm². Complies with ASTM D3577-09e1, ASTM D5151-06, ASTM D6124-06, and ASTM D5712. Biocompatibility confirmed via dermal sensitization and primary skin irritation studies.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination; tested for use with chemotherapy drugs.

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

• Encore Mark IV Powder-Free Surgical Gloves (K983489)
• Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for use with Chemotherapy Drugs Labeling Claim (K013302)

Submission Summary (Full Text)

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KI03714

# Ansell

JUL - 7 2011

1635 Industrial Road · Dothan, AL-36303-Tel: [phone] Fax: [phone]

| | 510(k) SUMMARY |
|-----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.0 | Submitter: Ansell Healthcare Products LLC<br>1635 Industrial Road<br>Dothan, AL 36303 |
| 2.0 | Contact Information: Cynthia A. Ingram, Regulatory Affairs Manager, Americas<br>Telephone: [phone] Fax: [phone] |
| 3.0 | Name of Device: |
| | Trade Name: Encore® Acclaim® Sterile Powder-Free Latex Surgical<br>Gloves, Tested for Use with Chemotherapy Drugs with a<br>Protein Content Label Claim <50µg/dm² per Glove of Extractable Protein |
| | Common Name: Surgeon's Gloves |
| | Classification Name: Surgeon's Gloves |
| 4.0 | Legally Marketed Devices to Which Equivalence is being Claimed: |

| Device Name: | Encore Mark IV Powder-Free Surgical Gloves |
|----------------|--------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K983489 |
| Device Name: | Duraprene Sterile Synthetic Powder-Free Surgical<br>Gloves with Tested for use with Chemotherapy<br>Drugs Labeling Claim |
| 510(k) Number: | K013302 |

- 5.0 Identification of the Device: Encore® Acclaim® Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim <50µg/dm² per Glove of Extractable Protein.
- 6.0 Description of the Device:

The Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim <50µg/dm2 per Glove of Extractable Protein, is a disposable device made of natural latex rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination, and is tested for use with chemotherapy drugs.

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#### 7.0 Intended Use of the Device:

A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has been tested for use with ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ chemotherapy drugs.

Chemotherapy Drug Permeation Chemotionals.crupy Drug Formediation
(average breakthrough detection time in minutes) (ASTM D6978-05)

| Vincristine Sulfate (1.0mg/mL) | >240 |
|---------------------------------------|-------|
| Carmustine (BiCNU)(3.3mg/mL) | 1.5 |
| Cyclophosphamide (Cytoxan)(20.0mg/mL) | >240 |
| Doxorubicin Hydrochloride (2.0mg/mL) | >240 |
| 5-Fluorouracil (50.0mg/mL) | >240 |
| Methotrexate (25.0mg/mL) | >240 |
| Etoposide (Toposar)(20.0mg/mL) | >240 |
| Paclitaxel (Toxol)(6.0mg/mL) | >240 |
| ThioTEPA (10.0mg/mL) | 15.26 |

Please note that Carmustine and ThioTEPA have extremely low permeation times of 1.5 and 15.26 minutes respectively.

- Summary of Technological Characteristics of the Device: 8.0
Encore Acclaim Sterile Powder-Free Latex Surgical Gloves , Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim <50μg/dm2 per Glove of Extractable Protein have the following technological characteristics compared to ASTM or equivalent standards:

| Characteristics | Standard | Device Performance |
|-----------------------|-------------------------------------------------------|--------------------|
| Dimensions | ASTM D3577-09e1 | Meets |
| Physical Properties | ASTM D3577-09e1 | Meets |
| Freedom from<br>Holes | ASTM D3577-09e1<br>ASTM D 5151-06 | Meets |
| Powder-Free | ASTM D 6124-06 | ≤ 2 mg per glove |
| Protein Content | ASTM D3577-09e1<br>ASTM D 5712 | Maximum 50 μg/dm2 |
| Biocompatibility | Dermal Sensitization<br>Primary Skin Irritation Study | Passes<br>Passes |

- Substantial Equivalence Based on Assessment of Non-Clinical Performance Data: 9.0 The subject device is substantially equivalent to the predicate devices based on an assessment of the non-clinical performance data.

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- Substantial Equivalence Based on an Assessment of Clinical Performance Data: 10.0 A clinical study was not conducted on the subject or predicate devices. ー・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
- 11.0 Conclusion:

The Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim <50µg/dm² per Glove of Extractable Protein is as safe and effective as the predicate devices. The subject device has been tested against the ASTM standards listed above and met the requirements of those standards.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

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

Ms. Cynthia A. Ingram Regulatory Affairs Manager. Americas Ansell Healthcare Products. LLC 1635 Industrial Road Dothan, Alabama 36303

JUL - 7 2011

Re: K103714

Trade/Device Name: Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim >50µg/dm² Per Glove of Extractable Protein Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO. LZC Dated: June 16. 2011 Received: June 17, 2011

Dear Ms. Ingram:

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.

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Page 2- Ms. Ingram

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm l 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D, ant

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement: 3.0

# INDICATIONS FOR USE

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

Device Name:

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Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim <50µg/dm² per Glove of Extractable Protein

## Indications For Use:

A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has been tested for use with chemotherapy drugs.

Chemotherapy Drug Permeation Chemoticlerapy Drag Formedion time in minutes) (ASTM D6978-05)

| Vincristine Sulfate (1.0mg/mL) | >240 |
|---------------------------------------|-------|
| Carmustine (BiCNU)(3.3mg/mL) | 1.5 |
| Cyclophosphamide (Cytoxan)(20.0mg/mL) | >240 |
| Doxorubicin Hydrochloride (2.0mg/mL) | >240 |
| 5-Fluorouracil (50.0mg/mL) | >240 |
| Methotrexate (25.0mg/mL) | >240 |
| Etoposide (Toposar)(20.0mg/mL) | >240 |
| Paclitaxel (Taxol)(6.0mg/mL) | >240 |
| ThioTEPA (10.0mg/mL) | 15.26 |

Please note that Carmustine and ThioTEPA have extremely low permeation times of 1.5 and 15.26 minutes respectively.

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Rophie Rangsukni, PhD.
7/16/2011

ision Sion-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103714