Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical examination glove and the description focuses on material properties and performance against standards, with no mention of AI/ML.

Therapeutic

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

Diagnostic

No

Explanation: The device is a patient examination glove, which is used for protection against contamination between a patient and examiner. Its stated purpose is not to provide diagnostic information.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove, which is a hardware device, not software. The description focuses on material properties and performance testing related to physical characteristics.

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 "disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient an examiner." This describes a barrier device for personal protection and infection control.
Device Description: The description focuses on the physical properties and performance of the glove as a barrier, including material (nitrile), sterility (non-sterile), powder content, and resistance to chemotherapy drugs.
Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not interact with patient specimens in this manner. It is a physical barrier.
Performance Studies and Metrics: The performance studies and metrics listed (watertightness, dimensions, tensile strength, elongation, powder content, chemotherapy drug resistance) are all related to the physical integrity and barrier function of the glove, not to the analysis of biological specimens.

Therefore, this device falls under the category of a medical device, specifically a patient examination glove, but it is not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 Breakthrough Detection Time in Minutes	Original Blue Average Breakthrough Detection Time in Minutes
Carboplatin, 10 mg/ml	>240	>240
Carmustine (BCNU), 3.3 mg/ml)	** 1.84	** 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	** 0.76	** 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.

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

LZA, LZC

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand or fingers

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner (medical purposes)

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)

Performance data of gloves based on ASTM D6319-10 and FDA 1000ML watertight test.
Test: FDA 1000ml Water Leak Test, Powder Free Nitrile Examination Gloves
Multiple Normal: GI AQL = 2.5
Original Blue: Pass
Cobalt Blue: Pass

Test: ASTM D6319-10
Length (mm)
Size M: Min 230 (chemo claim min 270) / 273 - 278 (Original Blue) / 276 - 278 (Cobalt Blue)
Size L: Min 230 (chemo claim min 270)

Palm width (mm)
Size M: 95 ± 10 / 97 - 99 (Original Blue) / 98 - 99 (Cobalt Blue)

Thickness (mm) (Single Layer)
Finger: Min 0.05 (chemo claim min0.10) / 0.15-0.21 (Original Blue) / 0.16-0.20 (Cobalt Blue)
Palm: Min 0.05 (chemo claim min0.10) / 0.11-0.12 (Original Blue) / 0.11-0.12 (Cobalt Blue)

Physical Properties
Before Aging
Tensile Strength (MPa): Min 14 / 20.3 - 25.9 (Original Blue) / 19.6 - 25.3 (Cobalt Blue)
Ultimate Elongation (%): Min 500 / 580 - 620 (Original Blue) / 560 - 580 (Cobalt Blue)

After Aging
Tensile Strength (MPa): Min 14 / 26.5 - 35.6 (Original Blue) / 25.0 - 28.4 (Cobalt Blue)
Ultimate Elongation (%): Min 400 / 500 - 520 (Original Blue) / 460 - 520 (Cobalt Blue)

Powder Content: Max 2.0mg/glove / 0.34 mg/glove (Original Blue) / 0.39 mg/glove (Cobalt Blue)
Moisture Content: Max 2.0% / 0.92% (Original Blue) / 0.84% (Cobalt Blue)

Key results: The performance data of the glove as shown above meet the ASTM D6319-05 Standard and FDA's 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 Sensitization (Buehler) test. For both colors The gloves pass the Bio-compatibility Test.

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

Watertight (1000ml) AQL = 2.5
Tensile Strength (Mpa)
Ultimate Elongation (%)
Finished Total Powder Level (mg/glove)
Minimum Breakthrough Detection Time in Minutes for various chemotherapy drugs.

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.

K101822

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

0

YTY INDUSTRY (MANJUNG) SDN. BHD.

(Company No : 380830-P) Lot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Tel : 05-6792288 (Hunting Line), 6792443 & 6792445 Fax : 05-6791188

DEC - 1 2011

2	-	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510 (K) SUMMARY SHEETS

1.0		SMDA 510 (K) SUMMARY
2.0	Submitter	YTY INDUSTRY (MANJUNG) SDN. BHD.,
Lot 1422-1424, Batu 10 Lekir
32020 Sitiawan, Perak
Malaysia
	Tel	605-6792288
	Fax	605-6791188
	Name of Contact Person	1. Mr. Roger Moh Ung Nang

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

1

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
Test	Powder Free Nitrile
Examination Gloves
	Multiple Normal	Original Blue	Cobalt Blue
1. Watertight (1000ml)	GI
AQL = 2.5	Pass	Pass

Test	ASTM D6319-10
2. Length (mm)
Size
M
L
XL	Min 230 (chemo claim min 270)
Min 230 (chemo claim min 270)	273 - 278	276 - 278
3. Palm width (mm)
Size
M	95 ± 10	97 - 99	98 - 99
4. Thickness (mm)
(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

2

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	240
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)

3

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

4

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 (800) 638-2041 or (301) 796-7100 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 .

6

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