NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)

K111248 · Yty Industry (Manjung) Sdn Bhd · LZA · Dec 1, 2011 · General Hospital

Device Facts

• Record ID: K111248
• Device Name: NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)
• Applicant: Yty Industry (Manjung) Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Dec 1, 2011
• 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 on the examiner's hand or fingers to prevent contamination between patient and examiner. This device is for over-the counter use.

Device Story

Disposable nitrile examination gloves; non-sterile; powder-free. Available in Original Blue and Cobalt Blue. Used by healthcare professionals or in over-the-counter settings to provide a protective barrier against contamination. Tested for resistance to permeation by chemotherapy drugs per ASTM D6978-05. Gloves act as a physical barrier; worn on hands/fingers. Protects both patient and examiner from cross-contamination. Performance verified via watertight testing and physical property assessment (tensile strength, elongation).

Clinical Evidence

Bench testing only. No clinical data. Performance verified against ASTM D6319-05 (physical properties, dimensions, powder content) and ASTM D6978-05 (chemotherapy drug permeation). Watertight integrity confirmed via FDA 1000ml water leak test (AQL 2.5). Biocompatibility confirmed via primary dermal irritation and Guinea Pig Maximization (Buehler) tests.

Technological Characteristics

Material: Nitrile rubber. Powder-free. Dimensions and physical properties meet ASTM D6319-05. Chemotherapy resistance tested per ASTM D6978-05. Biocompatibility: Passed primary skin irritation and sensitization tests. Non-sterile.

Indications for Use

Indicated for use as a disposable patient examination glove worn by examiners to prevent cross-contamination between patient and examiner. Suitable for use with specific chemotherapy drugs, excluding Carmustine and Thiotepa.

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

• Blue Nitrile Examination Gloves (K101822)

Submission Summary (Full Text)

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# YTY INDUSTRY (MANJUNG) SDN. BHD.

(Company No : 380830-P) Lot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Tel : [phone] (Hunting Line), 6792443 & 6792445 Fax : [phone]

DEC - 1 2011

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510 (K) SUMMARY SHEETS

| 1.0 | | SMDA 510 (K) SUMMARY |
|-----|--------------------------|--------------------------------------------------------------------------------------------------------------------------|
| 2.0 | Submitter | YTY INDUSTRY (MANJUNG) SDN. BHD.,<br>Lot 1422-1424, Batu 10 Lekir<br>32020 Sitiawan, Perak<br>Malaysia |
| | Tel | 605-6792288 |
| | Fax | 605-6791188 |
| | Name of Contact Person | 1. Mr. Roger Moh Ung Nang<br>2. Mr. Arivalagan |
| | Date of Summary Prepared | November 1, 2010 |
| 3.0 | Name of Device | |
| | Trade Name: | Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) Tested for use with Chemotherapy Drugs. |
| | Common Name: | Synthetic Rubber Examination Gloves |

Classification Name: Patient Examination Glove, Powder Free

Identification of The Legally Marketed Devices 4.0

> The legally marketed device to which we claim substantial equivalence is K101822, Blue Nitrile Examination Gloves, Tested for Use With Chemotherapy Drugs Labeling Claim, (Non-Sterle), which is a Class 1 device with Product Codes LZA/LZC. The predicate device was approved Nov 19, 2010, Except for the color differences, and some different chemotherapy chemicals broakthroughtesting times, we do claim this submission is essentially equivalent.

#### 5.0 Description of The Device

Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) Tested for use with Chemotherapy Drugs, meets all the current specifications listed under ASTM Specifications D6319-05 , Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05, Standard Practice for Assessment of Resistance to Permeation by Chemotherapy Drugs.

Page 1 of 1

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#### 6.0 The Intended Use of Glove

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. This device is for over-the counter use.

### Summary of Performance Data: 7.0

| Performance data of gloves based on ASTM D6319-10 and FDA 1000ML watertight test. | | | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------|---------------|
| Test | FDA 1000ml Water Leak<br>Test | Powder Free Nitrile<br>Examination Gloves | |
| | Multiple Normal | Original Blue | Cobalt Blue |
| 1. Watertight (1000ml) | GI<br>AQL = 2.5 | Pass | Pass |
| | | | |
| Test | ASTM D6319-10 | | |
| 2. Length (mm)<br>Size<br>M<br>L<br>XL | Min 230 (chemo claim min 270)<br>Min 230 (chemo claim min 270) | 273 - 278 | 276 - 278 |
| 3. Palm width (mm)<br>Size<br>M | 95 ± 10 | 97 - 99 | 98 - 99 |
| 4. Thickness (mm)<br>(Single Layer) | | | |
| Finger | Min 0.05 (chemo claim min0.10) | 0.15-0.21 | 0.16-0.20 |
| Palm | Min 0.05 (chemo claim min0.10) | 0.11-0.12 | 0.11-0.12 |
| 5. Physical Properties | | | |
| Before Aging | | | |
| Tensile Strength (MPa) | Min 14 | 20.3 - 25.9 | 19.6 - 25.3 |
| Ultimate Elongation (%) | Min 500 | 580 - 620 | 560 - 580 |
| After Aging | | | |
| Tensile Strength (MPa) | Min 14 | 26.5 - 35.6 | 25.0 - 28.4 |
| Ultimate Elongation (%) | Min 400 | 500 - 520 | 460 - 520 |
| 6. Powder Content | Max 2.0mg/glove | 0.34 mg/glove | 0.39 mg/glove |
| 7. Moisture Content | Max 2.0% | 0.92% | 0.84% |

Page 2 of 4

510 (k) Summary

Page 2 of 4 revised 10-20-2011

Joanna Rucker

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## SUBSTANTIAL EQUIVALENCE COMPARISONS

12111248

| TESTED PERFORMANCE DATA FOR BLUE | | | SGMP K101822 |
|-----------------------------------------------------------|-------------|-------------|--------------|
| YTY POWDER FREE NITRILE EXAM GLOVES | | | BLUE NITRILE |
| WITH CHEMO DRUG LABELING CLAIMS | | | CHEMO TESTED |
| ASTM D6319-05 NITRILE SPECIFICATION | | | |
| | ORIGINAL | COBALT | K101822 |
| FDA 1000ML Water Tight AOL | 2.5 | 2.5 | 2.5 |
| Length (mm) | 244-249 | 247-250 | 295 |
| Width (mm) | 97-99 | 98-99 | 95 |
| Thickness (mm) | | | |
| Finger: | 0.12 - 0.14 | 0.12 - 0.13 | 0.18 - 0.21 |
| Palm: | 0.06 - 0.07 | 0.07 - 0.08 | 0.16-0.19 |
| Tensile Strength (Mpa) | | | |
| Before Aging | 17.8 - 20.0 | 23/0 - 27.0 | 14 |
| After Aging | 21.3 - 23.6 | 30.2 - 34.6 | 14 |
| Ultimate Elongation (%) | | | |
| Before Aging | 680 - 720 | 660 - 680 | 500 |
| After Aging | 600 - 620 | 560 - 580 | 400 |
| Finished Total Powder Level (mg/glove | 0.48 | 0.22 | <2.0 |
| Biocompatibility Testing (CPTC) | | | |
| Pass Primary Skin Irritation in Rabbits | Yes | Yes | Yes |
| Pass Guinea Pig Maximization | Yes | Yes | Yes |
| CHEMOTHERAPY TESTING BY ARDL CHEMICAL ANALYTICAL SERVICES | | | |
| Minimum Breakthrough Detection Time in Minutes: | | | |
| Carboplatin, 10 mg/ml | >240 | >240 | Not tested |
| Carmustine (BCNU), 3.3 mg ml | 1.84 | 1.82 | 0.49 |
| Cisplatin, 1.0 mg/ml | >240 | >240 | >240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | >240 | >240 | >240 |
| Dacarbazine (DTIC), 10.0 mg/ml | >240 | >240 | >240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 | >240 | >240 |
| Etoposide (Toposar), 20.0 mg/ml | >240 | >240 | >240 |
| Fluorouracil, 50.0 mg/ml | >240 | >240 | >240 |
| Ifosfamide, 50,0 mgs/ml | >240 | >240 | Not tested |
| Methotrexate, 25 mg/ml | >240 | >240 | >240 |
| Mitomycin C. 0.5 mg/ml | >240 | >240 | Not tested |
| Mitoxantrone, 2 mg/ml | >240 | >240 | Not tested |
| Paclitaxel (Taxol), 6.0 mg/ml | >240 | >240 | >240 |
| Thiotepa, 10.0 mg/ml | 0.76 | 0.93 | 2.61 |
| Vincristine Sulfate, 1.0 mg/ml | >240 | >240 | >240 |

* WARNING: DO NOT USE WITH CARMUSTINE OR THIOTEPA´ is included as warnings on all three products (YTY and SGMP labeling claims)

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- The performance data of the glove as shown above meet the ASTM D6319-05 8.0 Standard and FDA's requirement. Standard and I DA 3 requirement.
Powder content is below 2 mg per glove which meet the FDA Requirements.
- The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig 9.0 Sensitization (Buehler) test. For both colors The gloves pass the Bio-compatibility Test.
- Conclusion 10.0

.

- We conclude that the Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, We Concided that the Non Sterth, Chemotherapy Drugs does meet:
- ASTM D6319-05 Standard
- FDA pinhole requirements -
- PDA philose requirements
Are below the maximum Powder Residual Content as specified in ASTM -D6319-02
- ASTM D5151 (which equates to the FDA Water Leak Test) -
- ASTM D6978-05 (Chemotherapy Testing Standards)

**Page**

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes, possibly representing human figures or waves, stacked on top of each other.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

DEC = 1 2011

YTY Industry (Manjung) Sdn. Bhd. C/O Ms. Janna P. Tucker Consultant Tucker & Associates 198 Avenue De La D'Emerald Sparks, Nevada 89434

Re: K111248

Trade/Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves (Original Blue, Cobalt Blue). Tested for Use with The Below Chemotherapy Drugs

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA, LZC Dated: November 10, 2011 Received: November 21, 2011

Dear Ms. Tucker:

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.

{5}------------------------------------------------

### Page 2 - Ms. Tucker

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, man

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

| APPLICANT: | YTY INDUSTRY (MANJUNG) SDN BHD |
|----------------|-----------------------------------------------------|
| 510(K) NUMBER: | K111248 |
| DEVICE NAME: | Non-Sterile, Powder Free Nitrile Examination Gloves |

Non-Sterile, Powder Free Nitrile Examination Gloves (Original Blue, Cobalt Blue). Tested for use with the below chemotherapy drugs.

INDICATIONS FOR USE:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient an examiner.

## Chemotherapy Drug Permeation (breakthrough detection time) in minutes. The following chemicals have been tested with these gloves:

| TESTED CHEMOTHERAPY DRUG | Original Blue Average<br>Breakthrough Detection<br>Time in Minutes | Original Blue Average<br>Breakthrough Detection<br>Time in Minutes |
|----------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|
| Carboplatin, 10 mg/ml | >240 | >240 |
| Carmustine (BCNU), 3.3 mg/ml) | **<br>1.84 | **<br>1.82 |
| Cisplatin, 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | >240 | >240 |
| Dacarbazine (DTIC), 10.0 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 | >240 |
| Etoposide (Toposar) 20.0 mg/ml | >240 | >240 |
| Fluorouracil, 50.0 mg/ml | >240 | >240 |
| Ifosfamide, 50.0 mg/ml | >240 | >240 |
| Methotrexate, 25 mg/ml | >240 | >240 |
| Mitomycin C, 0.5 mg/ml | >240 | >240 |
| Mitoxantrone, 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml | >240 | >240 |
| Thiotepa, 10.0 mg/ml | **<br>0.76 | **<br>0.93 |
| Vincristine Sulfate, 1.0 mg/ml | >240 | >240 |

** Please note that Carmustine (BCNU)and Thiotepa have extremely low permeation times for both glove colors. These two chemicals are not recommended for use with either color of the gloves.

**Prescription Use**
(Part 21 CFR 801.Subpart D

and/or

**Over-The-Counter**
21 CFR 801.Subpart C

Concurrence of CDRH, Office of Device Evaluation (ODE)

Adhip Ganguly
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

-10(k) Number: K111248