K Number

Device Name

POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)

Manufacturer

BETTER CARE PLASTIC TECHNOLOGY CO., LTD.

Date Cleared

2014-07-08

(98 days)

Product Code

LZA LZC

Regulation Number

880.6250

Intended Use

A patient examination glove is disposable non-sterile device intended for medical purpose 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 times are as follows: | Test Chemotherapy Drug and Concentration | Average BDT | |-------------------------------------------------|-------------| | Fluorouracil, 50.0mg/ml (50,000ppm) | >240 min. | | Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 min. | | Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | >240 min. | | Carmustine (BCNU), 3.3mg/ml (3,300ppm) | 2.3 min. | | Thiotepa, 10.0mg/ml (10,000ppm) | 30.9 min. | | Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | >240 min. | | Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 min. | | Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 min. | | Cisplatin, 1.0mg/ml (1,000ppm) | >240 min. | Please note that Carmustine and Thiotepa have extremely low permeation times of 30.9 minutes and 2.3 minutes, respectively.

Device Description

Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM standard D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K102096

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a standard examination glove and its performance characteristics against chemotherapy drugs. There is no mention of AI or ML technology in the intended use, device description, or performance studies.

Therapeutic

No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.

Diagnostic

Explanation: The device is described as a "patient examination glove," which is a protective barrier worn by an examiner to prevent contamination. Its function is to protect both the patient and the examiner, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device is a physical examination glove made of nitrile rubber, not a software application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as a "patient examination glove... worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device for protection, not a device used in vitro (outside the body) to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
Device Description: The description focuses on the physical characteristics and materials of the glove, and its compliance with standards for medical examination gloves.
Performance Studies: The performance studies described are related to the physical properties of the glove (pinhole requirements, biocompatibility) and its resistance to permeation by chemotherapy drugs. These are tests of the glove's barrier function and safety, not diagnostic tests.
Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, providing diagnostic information, or any other function typically associated with IVD devices.

The testing for chemotherapy drug permeation is a safety and performance characteristic of the glove as a barrier device, not a diagnostic function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A patient examination glove is disposable non-sterile device intended for medical purpose 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 times are as follows:

Test Chemotherapy Drug and Concentration	Average BDT
Fluorouracil, 50.0mg/ml (50,000ppm)	>240 min.
Etoposide (Toposar), 20.0mg/ml (20,000ppm)	>240 min.
Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm)	>240 min.
Carmustine (BCNU), 3.3mg/ml (3,300ppm)	2.3 min.
Thiotepa, 10.0mg/ml (10,000ppm)	30.9 min.
Paclitaxel (Taxol), 6.0mg/ml (6,000ppm)	>240 min.
Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm)	>240 min.
Dacarbazine (DTIC), 10.0mg/ml (10,000ppm)	>240 min.
Cisplatin, 1.0mg/ml (1,000ppm)	>240 min.

Please note that Carmustine and Thiotepa have extremely low permeation times of 30.9 minutes and 2.3 minutes, respectively.

Product codes (comma separated list FDA assigned to the subject device)

LZA, LZC

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests were performed for determination of substantial equivalence. The device conforms fully to ASTM D 6319-10 standard, applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims. Resistance to Permeation was tested per ASTM D6978-05.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K102096

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

JUL 0 8 2014

)

Product: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)

510 (K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 8807.92. ---

The assigned 510(K) number is: K140816

l . Owner's Identification:

Ms. Zhu Chunyan Better Care Plastic Technology Co., Ltd Fugian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

Tel: 86-311-83601854 Fax: 86-311-83616934

ﺮ Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Fax: 909-590-1511 Date Summary Prepared: June 18, 2014

2. Name of the Device:

Trade Name: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)

Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LZA Device Class: Class I

3. Predicate Device Information:

Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (K102096)

Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

Product: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)

4. Device Descrintion:

5. Intended Use of the Device:

A patient examination glove is disposable non-sterile device intended for medical purpose 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 times are as follows:

Test Chemotherapy Drug and Concentration	Average BDT
Fluorouracil, 50.0mg/ml (50,000ppm)	>240 min.
Etoposide (Toposar), 20.0mg/ml (20,000ppm)	>240 min.
Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm)	>240 min.
Carmustine (BCNU), 3.3mg/ml (3,300ppm)	2.3 min.
Thiotepa, 10.0mg/ml (10,000ppm)	30.9 min.
Paclitaxel (Taxol), 6.0mg/ml (6,000ppm)	>240 min.
Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm)	>240 min.
Dacarbazine (DTIC), 10.0mg/ml (10,000ppm)	>240 min.
Cisplatin, 1.0mg/ml (1,000ppm)	>240 min.

Please note that Carmustine and Thiotepa have extremely low permeation times of 30.9 minutes and 2.3 minutes, respectively.

6. Technological Characteristics and Substantial Equivalence:

Better Care Plastic Technology Co., Ltd's Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) is substantially equivalent in safety and effectiveness to the Syntex Healthcare Products Co., Ltd's Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (K102096). The subject device and predicate device use a similar plastic flexible barrier film to achieve a device for the intended use.

And the properties between the subject device and the predicate device are compared in the following table:

Characteristics	Standard	Device Performance		Result of comparison
		Predicate device	Subject Device
Product Code	/	LZA	LZA	Substantial
equivalence
Characteristics	Standard	Device Performance		Result of
comparison
		Predicate device	Subject Device
Intended Use	/	Predicate device is
disposable non-
sterile device
intended for
medical purpose
that is worn on the
examiner's hand or
finger to prevent
contamination
between patient and
examiner.
The average BDT for
tested chemotherapy
drugs of Fluorouracil,
50.0mg/ml
(50,000ppm),
Etoposide (Toposar),
20.0mg/ml
(20,000ppm),
Cyclophosphamide
(Cytoxan), 20mg/ml
(20,000ppm),
Paclitaxel (Taxol),
6.0mg/ml (6,000ppm),
Doxorubicin
Hydrochloride,
2.0mg/ml (2,000ppm),
Dacarbazine (DTIC),
10.0mg/ml
(10,000ppm),
Cisplatin, 1.0mg/ml
(1,000ppm)
is >240min, and
Carmustine and
Thiotepa have
extremely low
permeation times of
less than 30 minutes.	Subject device is
disposable non-
sterile device
intended for
medical purpose
that is worn on the
examiner's hand or
finger to prevent
contamination
between patient and
examiner.
The average BDT for
tested chemotherapy
drugs of Fluorouracil,
50.0mg/ml
(50,000ppm),
Etoposide (Toposar),
20.0mg/ml
(20,000ppm),
Cyclophosphamide
(Cytoxan), 20mg/ml
(20,000ppm),
Paclitaxel (Taxol),
6.0mg/ml (6,000ppm),
Doxorubicin
Hydrochloride,
2.0mg/ml (2,000ppm),
Dacarbazine (DTIC),
10.0mg/ml
(10,000ppm),
Cisplatin, 1.0mg/ml
(1,000ppm)
is >240min, and
Carmustine and
Thiotepa have
extremely low
permeation times of
30.9 mins and
2.3mins, respectively	Substantial
equivalence
Characteristics	Standard	Device Performance		Result of
comparison
		Predicate device	Subject Device
Labeling	/	There are no special
labeling claims and
do not claim gloves
as hypoallergenic
on labels.	There are no special
labeling claims and
do not claim gloves
as hypoallergenic
on labels.	Substantial
equivalence
Device Materials	/	Nitrile compound	Nitrile Compound	Substantial
equivalence
Color	/	Blue	Blue	Substantial
equivalence
Device tolerances and specifications & Performance Data:
Tensile strength:
before and after aging	ASTM
D6319-10	Meets	Meets	Substantial
equivalence
Ultimate elongation:
before and after aging	ASTM
D6319-10	Meets	Meets	Substantial
equivalence
Freedom from
pinholes	ASTM
D6319-10	Meets	Meets	Substantial
equivalence
Dimensions: Overall
length, Width, Palm
and Finger thickness	ASTM
D6319-10	Meets	Meets	Substantial
equivalence
Residual powder	ASTM
D6319-10,
ASTM
D6124	Meets	Meets	Substantial
equivalence
Biocompatibility
Primary skin irritation
test	ISO 10993-
10	Under conditions of
the study, not an
irritant	Under conditions of
the study, not an
irritant	Substantial
equivalence
Dermal sensitization
assay	ISO 10993-
10	Under conditions of
the study, not a
sensitizer	Under conditions of
the study, not a
sensitizer	Substantial
equivalence
Resistance to Permeation
Resistance to
Permeation	ASTM
D6978-05	Carmustine and
Thiotepa have
extremely low
permeation times of
less than 30
minutes.	Carmustine and
Thiotepa have
extremely low
permeation times of
30.9 minutes and
2.3 minutes,	Substantial
equivalence
Characteristics	Standard	Device Performance		Result of
comparison
		Predicate device	Subject Device
Indication for Use	/	It is disposable non-
sterile device
intended for
medical purpose
that is worn on the
examiner's hand or
finger to prevent
contamination
between patient and
examiner.

The average BDT for
tested chemotherapy
drugs of Fluorouracil,
50.0mg/ml
(50,000ppm),
Etoposide (Toposar),
20.0mg/ml
(20,000ppm),
Cyclophosphamide
(Cytoxan), 20mg/ml
(20,000ppm),
Paclitaxel (Taxol),
6.0mg/ml (6,000ppm),
Doxorubicin
Hydrochloride,
2.0mg/ml (2,000ppm),
Dacarbazine (DTIC),
10.0mg/ml
(10,000ppm),
Cisplatin, 1.0mg/ml
(1,000ppm)
is >240min, and
Carmustine and
Thiotepa have
extremely low
permeation times of
less than 30 minutes. | A patient
examination glove
is disposable non-
sterile device
intended for
medical purpose
that is worn on the
examiner's hand or
finger to prevent
contamination
between patient and
examiner.

The average BDT for
tested chemotherapy
drugs of Fluorouracil,
50.0mg/ml
(50,000ppm),
Etoposide (Toposar),
20.0mg/ml
(20,000ppm),
Cyclophosphamide
(Cytoxan), 20mg/ml
(20,000ppm),
Paclitaxel (Taxol),
6.0mg/ml (6,000ppm),
Doxorubicin
Hydrochloride,
2.0mg/ml (2,000ppm),
Dacarbazine (DTIC),
10.0mg/ml
(10,000ppm),
Cisplatin, 1.0mg/ml
(1,000ppm)
is >240min, and
Carmustine and
Thiotepa have
extremely low
permeation times of
30.9 mins and
2.3mins, respectively | Substantial
equivalence |

Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

Product: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) :

Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

Product: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)

Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

Product: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy -Drugs (Blue)

ર-5

Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

Product: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)

Better Care Plastic Technology Co., Ltd's Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) shares the same or comparable technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D6319-10. biocompatibility requirement and FDA requirements and the labeling claims for the product. It performs as well as the legally marketed predicate device.

| Characteristics | Applicable FDA- Recognized
Standards | Performance Results |
|---------------------------------------------------|------------------------------------------------------|------------------------|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from holes | ASTM D 6319-10
ASTM D5151-06(2011)
21CFR800.20 | Meets |
| Residual Powder Test | ASTM D 6319-10
ASTM D6124-06
(Reapproved 2011) | Meets |
| Primary Skin Irritation and
Skin Sensitization | ISO 10993 Part 10 | Meets |
| Resistance to Permeation | ASTM D6978-05 | See Data in Section 18 |

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as Follows:

8. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim. There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the nonclinical testing.

9. Labeling:

イ

Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) with a chemotherapy claim, which are tested per ASTM D6978, and provide protection against: Fluorouracil, Etoposide (Toposar), Cyclophosphamide (Cytoxan), Paclitaxel (Taxol), Doxorubicin Hydrochloride, Dacarbazine (DTIC), Cisplatin. Do not use with Carmustine and Thiotepa. The tested chemotherapy drugs' breakthrough detection times, refer to item 5 in this summary for details.

We do not claim our gloves as hypoallergenic on our labels.

Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

Product: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)

10. Conclusions:

Better Care Plastic Technology Co., Ltd's Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) conform fully to ASTM D 6319-10 standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data discussed above. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

Drawn from the complete list of non-clinical tests, the device herein mentioned is as safe, as effective, and performs as well as the legally marketed predicate device.

Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

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

July 8, 2014

Better Care Plastic Technology Company, Limited C/O Ms. Kathy Liu Official Correspondent Hongray USA Medical Products, Incorporated 3973 Schaefer Avenue Chino, CA 91710

Re: K140816

Trade/Device Name: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA, LZC Dated: June 4, 2014 Received: June 6, 2014

Dear Ms. Liu:

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.

Page 2 - Ms. Liu

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Maryner -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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

510(k) Number (if known) K140816

Device Name

Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)

Indications for Use (Describe)

A patient examination glove is disposable non-sterile device intended for medical purpose 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 times are as follows:

Test Chemotherapy Drug and Concentration	Average BDT
Fluorouracil, 50.0mg/ml (50,000ppm)	>240 min.
Etoposide (Toposar), 20.0mg/ml (20,000ppm)	>240 min.
Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm)	>240 min.
Carmustine (BCNU), 3.3mg/ml (3,300ppm)	2.3 min.
Thiotepa, 10.0mg/ml (10,000ppm)	30.9 min.
Paclitaxel (Taxol), 6.0mg/ml (6,000ppm)	>240 min.
Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm)	>240 min.
Dacarbazine (DTIC), 10.0mg/ml (10,000ppm)	>240 min.
Cisplatin, 1.0mg/ml (1,000ppm)	>240 min.

Please note that Carmusine and Thiotepa have extremely low permeation times of 2.3 minutes, respectively.

Type of Use (Select one or both, as applicable)

ال 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.

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

Sreekanth

ly signed by Sreekanth Gutala -S

US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 3.19200300.100.1.1=2000540490, cn=Sreekanth Gutala -S 0-2014.07.07 11:46:05 -04'00'

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