COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)

K121594 · Tekmedic (M) Sdn Bhd · LYY · Oct 25, 2012 · General Hospital

Device Facts

• Record ID: K121594
• Device Name: COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)
• Applicant: Tekmedic (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Oct 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder-free latex 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.

Device Story

Disposable powder-free latex examination glove; white or blue color. Worn on examiner's hand/finger to provide barrier protection against contamination between patient and examiner. Tested for permeation resistance against various chemotherapy drugs; provides specific breakthrough detection times (BDT) for drugs including Carmustine, Cisplatin, Cyclophosphamide, and others. Used in clinical settings by healthcare professionals. Provides physical barrier to reduce exposure to patient fluids and chemotherapy agents.

Clinical Evidence

Bench testing only. Permeation testing performed for various chemotherapy drugs to determine breakthrough detection times (BDT).

Technological Characteristics

Material: Latex. Form factor: Powder-free examination glove (white and blue). Barrier protection: Tested for chemotherapy drug resistance. Protein content: Claimed less than 50ug/dm2.

Indications for Use

Indicated for use by healthcare examiners to prevent cross-contamination between patient and examiner during medical procedures. Suitable for use with specific chemotherapy drugs as tested.

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.

Submission Summary (Full Text)

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

Tekmedic (M) Sdn Bhd Mr. Patrick Leong Chief Operation Officer Plot 4, Tanjung Kling Industrial Area Tanjung Bruas Jetty, Tanjung Kling Malacca, Malaysia 76400

Re: K121594

Trade/Device Name: Colored Powder Free Latex Examination Glove (White and Blue) Tested With Chemotherapy Drugs With A Protein Claim Of Less Than 50ug/dm-

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY, LZC Dated: October 18, 2012 Received: October 22, 2012

Dear Mr. Leong:

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.

OCT 25 2012

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## Page 2- Mr. Leong

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/ucm115809.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. 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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Premarket Notification For Colored Powder Free Latex Examination Glove (White And Blue) Tested With Chemotherapy Drugs with A Protein Claim Of Less Than 50μg/Dm2

## Indication For Use Statement · 4.0

K121594 510 (K) Number (if known) : ___

Device Name :

Colored Powder Free Latex Examination Glove (White and Blue) Tested With Chemotherapy Drugs With A Protein Claim Of Less Than 50ug/dm2

Indication For Use

A powder-free latex 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.

The tested chemotherapy drugs and their breakthrough detection time are as follows :

White Latex Powder Free

Blue Latex Powder.Free

| Chemotherapy Drugs | Average BDT |
|--------------------------------------|-------------|
| Carmustine (BCNU) 3.3mg/ml | 15.2 |
| Cisplatin 1.0mg/ml | >240 min |
| Cyclophosphamide (Cytoxan) 20.0mg/ml | >240 min |
| Dacarbazine (DTIC) 10.0mg/ml | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml | >240 min |
| Etoposide ( Toposar) 20.0 mg/ml | >240 min |
| Fluorouracil 50.0 mg/ml | >240 min |
| Ifosfamide 50.0 mg/ml | >240 min |
| Methotrexate 25.0 mg/ml | >240 min |
| Mitomycin C 0.5 mg/ml | >240 min |
| Mitoxantrone 2.0 mg/ml | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml | >240 min |
| Thiothepa 10.0 mg/ml | 15.2 |
| Vincristine Sulfate 1.0 mg/ml | >240 min |

Please note that the following drugs have extremely low permeation times:

* Carmustine - 15.2 minutes

* Thiotepa - 15.2 Minutes

Prescription Use Part 21 CFR 801 Subpart D

A verage Chemotherapy Drugs BDT Carmustine (BCNU) 3.3mg/ml 5.7 >240 min Cisplatin 1.0mg/ml >240 min Cyclophosphamide (Cytoxan) 20.0mg/ml >240 min Dacarbazine (DTIC) 10.0mg/ml Doxorubicin Hydrochloride 2.0 >240 min mg/ml >240 min Etoposide ( Toposar) 20.0 mg/ml >240 min Fluorouracil 50.0 mg/ml Ifosfamide 50.0 mg/ml >240 min >240 min Methotrexate 25.0 mg/ml >240 min Mitomycin C 0.5 mg/ml Mitoxantrone 2.0 mg/ml >240 min Paclitaxel (Taxol) 6.0 mg/ml >240 min 16.4 Thiothepa 10.0 mg/ml >240 min Vincristine Sulfate 1.0 mg/ml

Please note that the following drugs have extremely low permeation times:

* Carmustine - 5.7 minutes

* Thiotepa - 16.4 minutes

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)