Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)

K142283 · Yty Industry (Manjung) Sdn Bhd · LZA · Jan 16, 2015 · General Hospital

Device Facts

• Record ID: K142283
• Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)
• Applicant: Yty Industry (Manjung) Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jan 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Non Sterile. Powder Free Nitrile Examination Gloves [{8603F (AD) Blue Color, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, powder-free nitrile examination gloves; worn on examiner's hand/finger to prevent cross-contamination between patient and examiner. Manufactured from nitrile latex compound. Used in clinical or home settings by healthcare personnel or lay users. Device functions as a physical barrier; performance verified via ASTM D6319-10 standards for dimensions, physical properties, and freedom from holes. Output is the physical barrier provided by the glove material. Benefits include protection against contamination during medical examinations.

Clinical Evidence

Bench testing only. Performance data includes ASTM D6319-10 compliance for dimensions, physical properties (tensile strength, elongation), and freedom from holes (FDA 1000ml water leak test, AQL 2.5). Biocompatibility testing per ISO 10993-10 confirms device is non-irritant and a non-sensitizer.

Technological Characteristics

Material: Carboxylated butadiene acrylonitrile (nitrile latex). Form factor: Disposable, powder-free, non-sterile gloves. Standards: ASTM D6319-10 (dimensions, physical properties, freedom from holes), ASTM D6124-10 (residual powder), ISO 10993-10 (biocompatibility). No software or electronic components.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Intended for over-the-counter use.

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

• K052502

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines above them that resemble hair or a wave-like design.

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

January 16, 2015

YTY Industry (MANJUNG) SDN. BHD. Mr. Andrew Lowery Official Correspondent QA/GMP Consultant 14004 Manor Road, P O Box 445 Phoenix, Maryland 21131

Re: K142283

Trade/Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H), Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LZA Dated: December 13, 2014 Received: December 18, 2014

Dear Mr. Lowery:

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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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

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

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

### K142283

### Device Name

Non Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color]

### Indications for Use (Describe)

The Non Sterile. Powder Free Nitrile Examination Gloves [{8603F (AD) Blue Color, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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### 510 (K) SUMMARY SHEETS

| 1.0 | | 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 | 605-6908533 |
| | Fax | 605-6908501 |
| | Name of Contact Person | 1. Ms. Punitha Samy |
| | Date Summary Prepared | January 13, 2015 |
| 3.0 | Name of Device | |
| | Trade Name: | Non-Sterile, Powder Free Nitrile Examination Gloves<br>[(8603F (AD) Blue Color, 8611F (M) Blue Color, 8603F (Y4) Blue<br>Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C)Blue<br>Color, 8604T Black Color and 8617F White Color] |
| | Common Name: | Nitrile Examination Gloves |
| | Classification Name: | Patient Examination Gloves, Powder Free |
| | Device Classification: | I |
| | Regulation Number: | 21 CFR 880.6250 |
| | Panel: | General Hospital (80) |
| | Product Code: | LZA |

#### 4.0 Identification of The Legally Marketed Devices

Non Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] as described in this 510k Notification is substantially equivalent to the current Class I patient examination gloves bearing the product code 80LZA (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Gloves for Medical Application. Predicate 510(K) number for this application is K052502.

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#### 5.0 Description of The Device

Non-Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. This device is for over-the counter single use. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

#### 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 finger to prevent contamination between patient and examiner. This device is for over-the counter use.

#### 7.0 Summary of Performance Data:

There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-sterile, Powder Free Nitrile Examination [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C)Blue Color, 8604T Black Color and 8617F White Color] Gloves have the below technological characteristic compared to ASTM or Equivalent standards.

| Characteristic | Standards | Performance of<br>Non-Sterile, Powder Free<br>Nitrile Examination Gloves |
|---------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Dimension | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 | Meets |
| Freedom from holes | ASTM D6319-10 | Meets |
| Powder-free | ASTM D6319-10 | Meets |
| Bio-compatibility | Primary skin irritation<br>ISO 10993-10<br>Dermal Sensitization<br>ISO 10993-10 | Non-Irritant<br>Non-sensitizer |

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| | Performance data of gloves based on ASTNI D6519-10 and FDA 1000ML water leak test. | | | | | | | | |
|----------------------------|------------------------------------------------------------------------------------|--------------------------------------------|---------------|---------------|---------------|-------------|---------------|----------------|-------------|
| Test | FDA | YTY Powder Free Nitrile Examination Gloves | | | | | | | |
| | 1000ml | | | | | | | | |
| | Water | | | | | | | | |
| | Leak Test | | | | | Blue 8603 | | | White |
| 1. Watertight | Multiple<br>Normal | Blue<br>8603F | Blue<br>8611F | Blue<br>8603F | Blue<br>8613F | (H) | Blue<br>8612F | Black<br>8604T | 8617F |
| (1000ml) ASTM | GII AQL = | (AD) | (M) | (Y4) | | | (C) | | |
| D5151-06 (2011) | 2.5 | | | | | | | | |
| | Lot size: | Holes | Holes | Holes | Holes | Holes | Holes | Holes | Holes |
| | 16,000 | found: 0 | found: 0 | found: 0 | found: 0 | found: 0 | found: 0 | found: 0 | found: 0 |
| | Sample | (Accept 5, | (Accept 5, | (Accept 5, | (Accept 5, | (Accept 5, | (Accept 5, | (Accept 5, | (Accept 5, |
| | | Reject 6) | Reject 6) | Reject 6) | Reject 6) | Reject 6) | Reject 6) | Reject 6) | Reject 6) |
| | Size: 80 | | | | | | | | |
| Test<br>ASTM D6319-10 | ASTM | | | | | | | | |
| 2. Length (mm) | D6319-10 | | | | | | | | |
| Size<br>M | Min 230 | 240-247 | 240-248 | 241-247 | 244-252 | 240-247 | 247-253 | 245-253 | 245-253 |
| | | | | | | | | | |
| 3. Palm width (mm) | | | | | | | | | |
| Size<br>M | | | | | | | | | |
| | 95 + 10 | 95-97 | 97-99 | 95-97 | તેર-તેત્ર | 95-97 | 96-97 | 96-99 | 96-98 |
| | | | | | | | | | |
| 4. Thickness (mm) | | | | | | | | | |
| (Single Layer) | | | | | | | | | |
| Finger | Min 0.05 | 0.10-0.12 | 0.09-0.11 | 0.10-0.12 | 0.09-0.12 | 0.11-0.14 | 0.08-0.10 | 0.13-0.16 | 0.10-0.12 |
| Palm | Min 0.05 | 0.07-0.08 | 0.06-0.07 | 0.06-0.07 | 0.06 | 0.06-0.07 | 0.06-0.07 | 0.10-0.12 | 0.06-0.08 |
| | | | | | | | | | |
| 5. Physical<br>Properties | | | | | | | | | |
| Before Aging | | | | | | | | | |
| Tensile Strength | Min 14 | 25.90- | 25.59- | 25.09- | 23.14- | 23.33- | 24.64- | 20.51- | 22.70- |
| (MPa) | | 32.06 | 31.07 | 30.66 | 29.50 | 29.02 | 28.78 | 23.75 | 29.88 |
| Ultimate Elongation | Min 500 | 540-580 | 560-600 | 580-600 | 520-560 | 520-540 | 560-600 | 540-560 | 540-580 |
| (%) | | | | | | | | | |
| | | | | | | | | | |
| After Aging | | | | | | | | | |
| Tensile Strength | Min 14 | 28.40- | 26.54- | 30.72- | 26.53- | 28.04- | 24.14- | 23.81- | 23.90- |
| (MPa) | | 33.92 | 32.19 | 37.60 | 33.17 | 33.98 | 28.78 | 31.78 | 31.77 |
| Ultimate Elongation | Min 400 | 460-500 | 480-520 | 500-540 | 460-500 | 480-500 | 560-600 | 460-520 | 460-520 |
| (%) | | | | | | | | | |
| 6. Moisture Content<br>(%) | Max 2.0% | 0.99% | 1.1% | 1.0% | 1.0% | 1.2% | 1.1% | 0.8% | 1.0% |
| | | Average | Average | Average | Average | Average | Average | Average | Average |
| 7. Residual Powder | Max 2.0mg/ | | | | | | | | |
| ASTM-D6124-10 | glove | 0.20mg/ | 0.12mg/ | 0.10mg/ | 0.14mg/ | 0.16mg/ | 0.16mg/ | 0.16mg/ | 0.14mg/ |
| (Reapproved 2011) | | glove | glove | glove | glove | glove | glove | glove | glove |
| | | | | | | | | | |
| 8. Biocompatibility | ISO 10993- | Under the | Under the | Under the | Under the | Under the | Under the | Under the | Under the |
| Primary Skin | 10 | condition | condition | condition | condition | condition | condition | condition | condition |
| Irritation | Non-irritant | s of the | s of the | s of the | s of the | s of the | s of the | s of the | s of the |
| Dermal | Non- | study, | study, | study, | study, | study, | study, | study, | study, |
| Sensitization | sensitizer | the | the device | the | the device | the | the device | the | the |
| | | device is | is non- | device is | is non- | device is | is non- | device is | device is |
| | | non- | irritant or | non- | irritant or | non- | irritant or | non- | non- |
| | | irritant or | non- | irritant or | non- | irritant or | non- | irritant or | irritant or |
| | | non- | sensitizer | non- | sensitizer | non- | sensitizer | non- | non- |
| | | sensitizer | | sensitizer | | sensitizer | | sensitizer | sensitizer |
| | | | | | | | | | |

Performance data of gloves based on ASTM D6319-10 and FDA 1000ML water leak test

Sec 1 Sum Page 3 of 6

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| 8.0 | Substantial Equivalence Comparison Table with Predicate Device, K052502 |
|-----|-------------------------------------------------------------------------|
|-----|-------------------------------------------------------------------------|

| | K142283 | | | | | | | | | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Blue<br>Glove<br>8603F<br>(AD) | Blue<br>Glove<br>8611F<br>(M) | Blue<br>Glove<br>8603F<br>(Y4) | Blue<br>Glove<br>8613F | Blue<br>Glove<br>8603<br>(H) | Blue<br>Glove<br>8612F<br>(C) | Black<br>Glove<br>8604T | White<br>Glove<br>8617F | Predicate K052502 | Medical Glove<br>Manual (1661) |
| Company Name | | | | YTY Industry (Manjung) Sdn Bhd | | | | | YTY Industry<br>(Manjung) Sdn Bhd | FDA |
| Product Name | Non-sterile, Powder Free Nitrile Examination [(8603F (AD) Blue<br>Color, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F Blue<br>Color, 8603F (H) Blue Color, 8612F (C)Blue Color, 8604T Black<br>Color and 8617F White Color] | | | | | | Non-Sterile, On<br>Line Powder Free<br>Nitrile Blue &<br>White Color<br>Examination<br>Gloves | Patient<br>Examination<br>Gloves | | |
| Product Code | LZA | | | | | | | | LZA | LZA - (Polymer -<br>other than Vinyl<br>(includes Nitrile,<br>Polyurethane, etc.) |
| Indication for Use | | | | A patient examination gloves is a disposable device intended for medical<br>purpose that is worn on the examiner's hand or fingers to prevent<br>contamination between patient and examiner. | | | | | This is a medical<br>glove to be worn on<br>the hand of health<br>care and similar<br>personnel to prevent<br>contam ination<br>between health care<br>personnel and the<br>patient. | Powder-Free<br>Examination<br>Gloves<br>A powder-free<br>patient<br>examination glove<br>is a disposable<br>device intended<br>for medical<br>purposes that is<br>worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient<br>and examiner. |
| Device<br>Description | | counter single use. | | Non Sterile, Powder Free Nitrile Exam ination Gloves [(8603F (AD) Blue<br>Color, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color,<br>8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and<br>8617F White Color] meets all the current specifications listed under the<br>ASTM Specification D6319-10, Standard Specification for Nitrile<br>Examination Gloves for Medical Application. This device is for over-the | | | | | Class 1 Nitrile<br>Patient Examination<br>Glove 80 LZA,<br>powder free that<br>meets all<br>requirements of<br>ASTM Standard<br>D6319-00a63 and<br>FDA water leak<br>test. | This gloves meet<br>all current<br>specifications<br>listed under<br>ASTM<br>specifications<br>D6319-10 |
| Over the Counter<br>Use | This device is for over-the counter single use. | | | | | | This device is for<br>over-the counter<br>single use. | Indication for use | | |
| Single Use | Single Use | | Single Use | Misbranding | | | | | | |
| Non Sterile or<br>Sterile | Non Sterile | | | | | Non Sterile | Sterilization | | | |
| Powder Free | Powder Free | | | | | | | Powder Free | Process &<br>Attribute labelin g | |
| Compare materials | | | | | | | | | | |
| Materials | | Carboxylated Butadiene Acrylonitrile | | | | | | | Carboxylated<br>Butadiene<br>Acrylon itrile | LZA - (Polymer -<br>other than Vinyl<br>(includes Nitrile,<br>Polyurethane, etc.) |

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| | K142283 | | | | | | | | | | | | | | | |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|--------------------------------|--|--------------------------|--------------------------|----------------------|--------------------------------------|
| | Blue<br>Glove<br>8603F<br>(AD) | | Blue<br>Glove<br>8611F<br>(M) | | Blue<br>Glove<br>8603F<br>(Y4) | | Blue<br>Glove<br>8613F<br>(FI) | | Blue<br>Glove<br>8603<br>(H) | | Blue<br>Glove<br>8612F<br>(C ) | | Black<br>Gloves<br>8604T | White<br>Gloves<br>8617F | Predicate<br>K052502 | Medical<br>Glove<br>Manual<br>(1661) |
| Characteristics | | | | | | | | | | | | | | | | |
| Specifications<br>and<br>Performance | | | | | | | | | | | | | | | | |
| Tensile<br>Strength before<br>aging (MPa) | 25-59-<br>31.07 | 25.59-<br>31.07 | 25.09-<br>30.66 | 23.14-<br>29.50 | 23.33-<br>29.02 | 24.64-<br>28.78 | 20.51-<br>23.75 | 22.70-<br>29.88 | 26.00-<br>30.00 | Current gloves<br>meet ASTM<br>D6319-10 | | | | | | |
| Tensile<br>Strength after<br>aging (MPa) | 28.40-<br>33.92 | 26.54-<br>32.19 | 30.72-<br>37.60 | 26.53-<br>33.17 | 28.04-<br>33.98 | 24.14-<br>28.78 | 23.81-<br>31.78 | 23.90-<br>31.77 | 25.00-<br>28.00 | Nitrile gloves<br>ASTM<br>D6124-06 | | | | | | |
| | | | | | | | | | | (Reapproved<br>2011)<br>Residual<br>Powder | | | | | | |
| Ultimate<br>Elongation<br>before aging<br>(%) | 540-580 | 560-600 | 580-600 | 520-560 | 520-540 | 560-600 | 540-560 | 540-580 | 750-800 | | | | | | | |
| Ultimate<br>Elongation after<br>aging (%) | 460-500 | 480-520 | 500-540 | 460-500 | 480-500 | 560-600 | 460-520 | 460-520 | 670-730 | ASTM<br>D5151-06<br>(Reapproved<br>2011) | | | | | | |
| Dimensions<br>Length (mm) | 240-247 | 240-248 | 241-247 | 244-252 | 240-247 | 247-253 | 245-253 | 245-253 | 240-251 | | | | | | | |
| Dimensions<br>Width (mm) | 95-97 | 97-99 | 95-97 | 95-99 | 95-97 | 96-97 | 96-99 | 96-98 | 94-96 | Detection of<br>Holes in<br>Medical<br>Gloves | | | | | | |
| Thickness<br>Finger (mm) | 0.10-<br>0.12 | 0.09-<br>0.11 | 0.10-<br>0.12 | 0.09-<br>0.12 | 0.11-<br>0.14 | 0.08-<br>0.10 | 0.13-<br>0.16 | 0.10-<br>0.12 | 0.15-0.19 | | | | | | | |
| Thickness Palm<br>(mm) | 0.07-<br>0.08 | 0.06-<br>0.07 | 0.06-<br>0.07 | 0.06 | 0.06-<br>0.07 | 0.06-<br>0.07 | 0.10-<br>0.12 | 0.06-<br>0.08 | 0.12-<br>0.16 | | | | | | | |
| AQL (As per<br>FDA<br>requirement) | Multiple<br>Normal<br>Samplin<br>g<br>GII<br>AQL<br>2.5<br>Lot size:<br>16,000<br>Sample<br>Size: 80<br>Acc: 5<br>Rej: 6<br>Result:<br>0 | Multiple<br>Normal<br>Samplin<br>g<br>GII<br>AQL<br>2.5<br>Lot size:<br>16,000<br>Sample<br>Size: 80<br>Acc: 5<br>Rej: 6<br>Result:<br>0 | Multiple<br>Normal<br>Samplin<br>g<br>GII<br>AQL<br>2.5<br>Lot size:<br>16,000<br>Sample<br>Size: 80<br>Acc: 5<br>Rej: 6<br>Result:<br>0 | Multiple<br>Normal<br>Samplin<br>g<br>GII<br>AQL<br>2.5<br>Lot size:<br>16,000<br>Sample<br>Size: 80<br>Acc: 5<br>Rej: 6<br>Result:<br>0 | Multiple<br>Normal<br>Samplin<br>g<br>GII<br>AQL<br>2.5<br>Lot size:<br>16,000<br>Sample<br>Size: 80<br>Acc: 5<br>Rej: 6<br>Result:<br>0 | Multiple<br>Normal<br>Samplin<br>g<br>GII<br>AQL<br>2.5<br>Lot size:<br>16,000<br>Sample<br>Size: 80<br>Acc: 5<br>Rej: 6<br>Result:<br>0 | Multiple<br>Normal<br>Samplin<br>g<br>GII<br>AQL<br>2.5<br>Lot size:<br>16,000<br>Sample<br>Size: 80<br>Acc: 5<br>Rej: 6<br>Result:<br>0 | Multiple<br>Normal<br>Samplin<br>g<br>GII<br>AQL<br>2.5<br>Lot size:<br>16,000<br>Sample<br>Size: 80<br>Acc: 5<br>Rej: 6<br>Result:<br>0 | Multiple<br>Normal<br>Sampling<br>GII<br>AQL 2.5<br>Lot size:<br>16,000<br>Sample<br>Size: 80<br>Acc: 5<br>Rej: 6<br>Result: 0 | | | | | | | |
| Residual<br>Powder<br>(mg/glove) | 0.99%<br>Average | 1.1%<br>Avg. | 1.0%<br>Avg. | 1.0%<br>Avg. | 1.2%<br>Avg. | 1.1%<br>Avg. | 0.8%<br>Avg. | 1.0%<br>Avg. | 0.20%<br>Avg. | | | | | | | |
| Size | M | M | M | M | M | M | M | M | M | | | | | | | |

{8}------------------------------------------------

| Characteristics | Blue<br>Glove<br>8603F<br>(AD) | Blue<br>Glove<br>8611F<br>(M) | Blue<br>Glove<br>8603F<br>(Y4) | Blue<br>Glove<br>8613F | K142283<br>Blue<br>Glove<br>8603 (H) | Blue<br>Glove<br>8612F<br>(C ) | Black<br>Gloves<br>8604T | White<br>Gloves<br>8617F | Predicate<br>K052502 | Medical<br>Glove<br>Manual<br>(1661) |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Biocompatibility | Under<br>the<br>conditio<br>n of the<br>study the<br>device is<br>non-<br>irritant<br>and non-<br>sensitize<br>r | Under<br>the<br>conditio<br>n of the<br>study<br>the<br>device<br>is non-<br>irritant<br>and<br>non-<br>sensitiz<br>er | Under<br>the<br>condit<br>ion of<br>the<br>study<br>the<br>device<br>is<br>non-<br>irritant<br>and<br>non-<br>sensiti<br>zer | Under<br>the<br>condit<br>ion of<br>the<br>study<br>the<br>device<br>is<br>non-<br>irritant<br>and<br>non-<br>sensiti<br>zer | Under<br>the<br>conditio<br>n of the<br>study the<br>device is<br>non-<br>irritant<br>and non-<br>sensitize<br>r | Under<br>the<br>conditio<br>n of the<br>study the<br>device is<br>non-<br>irritant<br>and non-<br>sensitize<br>r | Under<br>the<br>condition<br>of the<br>study the<br>device is<br>non-<br>irritant<br>and non-<br>sensitizer | Under<br>the<br>conditio<br>n of the<br>study<br>the<br>device is<br>non-<br>irritant<br>and non-<br>sensitize<br>r | Non-irritant<br>Non-sensitizer | ISO 10993-10<br>Skin Irritant<br>Dermal and<br>Sensitization<br>studies |
| Labeling for<br>legally<br>marketed<br>predicate | | | | | | | | | -Powder Free<br>-devices<br>color:<br>Clear(Blue)<br>-Patient<br>Examination<br>Glove<br>-Non sterile<br>-Single Use<br>Only<br>Manufactured<br>For:<br>- Lot | Chapter 4 -<br>Labeling |

### 9.0 S…