(154 days)
Not Found
No
The device is a physical barrier (examination gloves) and the description focuses on material properties and performance standards, with no mention of AI or ML.
No.
The device is described as a non-sterile disposable device intended to prevent contamination between patient and examiner, serving a protective function rather than a therapeutic one.
No
The device description clearly states its purpose is to "prevent contamination between patient and examiner," not to diagnose a condition.
No
The device is described as physical examination gloves made of nitrile, which are a hardware product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and barrier function of the gloves, meeting standards for medical examination gloves. It does not describe any components or mechanisms for analyzing biological samples.
- Performance Studies and Key Metrics: The performance data and key metrics relate to the integrity and physical properties of the gloves (freedom from holes, tensile strength, elongation, etc.), which are relevant to their barrier function. They do not involve any diagnostic measurements or analysis of biological markers.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
In summary, these nitrile examination gloves are a medical device intended for barrier protection, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's hand or finger / medical purpose
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 water leak test, and biocompatibility testing (Primary skin irritation ISO 10993-10: Non-Irritant, Dermal Sensitization ISO 10993-10: Non-sensitizer).
Watertight (1000ml) ASTM D5151-06 (2011): Multiple Normal GII AQL = 2.5, Lot size: 16,000, Sample Size: 80, Holes found: 0 (Accept 5, Reject 6) for all listed glove types.
Length (mm) Size M: 240-253 for all listed glove types.
Palm width (mm) Size M: 95-99 for all listed glove types.
Thickness (mm) (Single Layer) Finger: 0.08-0.16 for all listed glove types.
Thickness (mm) (Single Layer) Palm: 0.06-0.12 for all listed glove types.
Physical Properties:
Before Aging:
Tensile Strength (MPa): 20.51-32.06 for all listed glove types (Min 14 (ASTM D6319-10)).
Ultimate Elongation (%): 520-600 for all listed glove types (Min 500 (ASTM D6319-10)).
After Aging:
Tensile Strength (MPa): 23.81-37.60 for all listed glove types (Min 14 (ASTM D6319-10)).
Ultimate Elongation (%): 460-600 for all listed glove types (Min 400 (ASTM D6319-10)).
Moisture Content (%): Average 0.8%-1.2% for all listed glove types (Max 2.0% (ASTM D6319-10)).
Residual Powder: Average 0.10mg/glove-0.20mg/glove for all listed glove types (Max 2.0mg/glove (ASTM-D6124-10 (Reapproved 2011))).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Ultimate Elongation, Tensile Strength, Freedom from holes, Residual Powder, Bio-compatibility (Primary skin irritation, Dermal Sensitization)
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.
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
§ 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.
0
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
510 (K) SUMMARY SHEETS
| 1.0 | 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | YTY INDUSTRY (MANJUNG) SDN. BHD., |
| Lot 1422-1424, Batu 10 Lekir | ||
| 32020 Sitiawan, Perak | ||
| 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 | |
| [(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] | ||
| 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.
4
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
Non-Sterile, Powder Free
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
ISO 10993-10
Dermal Sensitization
ISO 10993-10 | Non-Irritant
Non-sensitizer |
5
| 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 | ||||||||
| Normal | Blue | ||||||||
| 8603F | Blue | ||||||||
| 8611F | Blue | ||||||||
| 8603F | Blue | ||||||||
| 8613F | (H) | Blue | |||||||
| 8612F | Black | ||||||||
| 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 | |||||||||
| ASTM D6319-10 | ASTM | ||||||||
| 2. Length (mm) | D6319-10 | ||||||||
| Size | |||||||||
| M | Min 230 | 240-247 | 240-248 | 241-247 | 244-252 | 240-247 | 247-253 | 245-253 | 245-253 |
| 3. Palm width (mm) | |||||||||
| Size | |||||||||
| 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 | |||||||||
| 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 | |||||||||
| (%) | 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
6
| 8.0 | Substantial Equivalence Comparison Table with Predicate Device, K052502 |
|---|---|
| ----- | ------------------------------------------------------------------------- |
| K142283 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Characteristics | Blue | |||||||||
| Glove | ||||||||||
| 8603F | ||||||||||
| (AD) | Blue | |||||||||
| Glove | ||||||||||
| 8611F | ||||||||||
| (M) | Blue | |||||||||
| Glove | ||||||||||
| 8603F | ||||||||||
| (Y4) | Blue | |||||||||
| Glove | ||||||||||
| 8613F | Blue | |||||||||
| Glove | ||||||||||
| 8603 | ||||||||||
| (H) | Blue | |||||||||
| Glove | ||||||||||
| 8612F | ||||||||||
| (C) | Black | |||||||||
| Glove | ||||||||||
| 8604T | White | |||||||||
| Glove | ||||||||||
| 8617F | Predicate K052502 | Medical Glove | ||||||||
| Manual (1661) | ||||||||||
| Company Name | YTY Industry (Manjung) Sdn Bhd | YTY Industry | ||||||||
| (Manjung) Sdn Bhd | FDA | |||||||||
| Product Name | 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] | Non-Sterile, On | |||||||||
| Line Powder Free | ||||||||||
| Nitrile Blue & | ||||||||||
| White Color | ||||||||||
| Examination | ||||||||||
| Gloves | Patient | |||||||||
| Examination | ||||||||||
| Gloves | ||||||||||
| Product Code | LZA | LZA | LZA - (Polymer - | |||||||
| other than Vinyl | ||||||||||
| (includes Nitrile, | ||||||||||
| Polyurethane, etc.) | ||||||||||
| Indication for Use | 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 is a medical | |||||||||
| glove to be worn on | ||||||||||
| the hand of health | ||||||||||
| care and similar | ||||||||||
| personnel to prevent | ||||||||||
| contam ination | ||||||||||
| between health care | ||||||||||
| personnel and the | ||||||||||
| patient. | Powder-Free | |||||||||
| Examination | ||||||||||
| Gloves | ||||||||||
| A powder-free | ||||||||||
| 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. | ||||||||||
| Device | ||||||||||
| Description | counter single use. | Non Sterile, Powder Free Nitrile Exam ination 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 | Class 1 Nitrile | |||||||||
| Patient Examination | ||||||||||
| Glove 80 LZA, | ||||||||||
| powder free that | ||||||||||
| meets all | ||||||||||
| requirements of | ||||||||||
| ASTM Standard | ||||||||||
| D6319-00a63 and | ||||||||||
| FDA water leak | ||||||||||
| test. | This gloves meet | |||||||||
| all current | ||||||||||
| specifications | ||||||||||
| listed under | ||||||||||
| ASTM | ||||||||||
| specifications | ||||||||||
| D6319-10 | ||||||||||
| Over the Counter | ||||||||||
| Use | This device is for over-the counter single use. | This device is for | ||||||||
| over-the counter | ||||||||||
| single use. | Indication for use | |||||||||
| Single Use | Single Use | Single Use | Misbranding | |||||||
| Non Sterile or | ||||||||||
| Sterile | Non Sterile | Non Sterile | Sterilization | |||||||
| Powder Free | Powder Free | Powder Free | Process & | |||||||
| Attribute labelin g | ||||||||||
| Compare materials | ||||||||||
| Materials | Carboxylated Butadiene Acrylonitrile | Carboxylated | ||||||||
| Butadiene | ||||||||||
| Acrylon itrile | LZA - (Polymer - | |||||||||
| other than Vinyl | ||||||||||
| (includes Nitrile, | ||||||||||
| Polyurethane, etc.) |
7
| K142283 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Blue | ||||||||||||||||
| Glove | ||||||||||||||||
| 8603F | ||||||||||||||||
| (AD) | Blue | |||||||||||||||
| Glove | ||||||||||||||||
| 8611F | ||||||||||||||||
| (M) | Blue | |||||||||||||||
| Glove | ||||||||||||||||
| 8603F | ||||||||||||||||
| (Y4) | Blue | |||||||||||||||
| Glove | ||||||||||||||||
| 8613F | ||||||||||||||||
| (FI) | Blue | |||||||||||||||
| Glove | ||||||||||||||||
| 8603 | ||||||||||||||||
| (H) | Blue | |||||||||||||||
| Glove | ||||||||||||||||
| 8612F | ||||||||||||||||
| (C ) | Black | |||||||||||||||
| Gloves | ||||||||||||||||
| 8604T | White | |||||||||||||||
| Gloves | ||||||||||||||||
| 8617F | Predicate | |||||||||||||||
| K052502 | Medical | |||||||||||||||
| Glove | ||||||||||||||||
| Manual | ||||||||||||||||
| (1661) | ||||||||||||||||
| Characteristics | ||||||||||||||||
| Specifications | ||||||||||||||||
| and | ||||||||||||||||
| Performance | ||||||||||||||||
| Tensile | ||||||||||||||||
| Strength before | ||||||||||||||||
| aging (MPa) | 25-59- | |||||||||||||||
| 31.07 | 25.59- | |||||||||||||||
| 31.07 | 25.09- | |||||||||||||||
| 30.66 | 23.14- | |||||||||||||||
| 29.50 | 23.33- | |||||||||||||||
| 29.02 | 24.64- | |||||||||||||||
| 28.78 | 20.51- | |||||||||||||||
| 23.75 | 22.70- | |||||||||||||||
| 29.88 | 26.00- | |||||||||||||||
| 30.00 | Current gloves | |||||||||||||||
| meet ASTM | ||||||||||||||||
| D6319-10 | ||||||||||||||||
| Tensile | ||||||||||||||||
| Strength after | ||||||||||||||||
| aging (MPa) | 28.40- | |||||||||||||||
| 33.92 | 26.54- | |||||||||||||||
| 32.19 | 30.72- | |||||||||||||||
| 37.60 | 26.53- | |||||||||||||||
| 33.17 | 28.04- | |||||||||||||||
| 33.98 | 24.14- | |||||||||||||||
| 28.78 | 23.81- | |||||||||||||||
| 31.78 | 23.90- | |||||||||||||||
| 31.77 | 25.00- | |||||||||||||||
| 28.00 | Nitrile gloves | |||||||||||||||
| ASTM | ||||||||||||||||
| D6124-06 | ||||||||||||||||
| (Reapproved |
Residual
Powder | | | | | | |
| Ultimate
Elongation
before aging
(%) | 540-580 | 560-600 | 580-600 | 520-560 | 520-540 | 560-600 | 540-560 | 540-580 | 750-800 | | | | | | | |
| Ultimate
Elongation after
aging (%) | 460-500 | 480-520 | 500-540 | 460-500 | 480-500 | 560-600 | 460-520 | 460-520 | 670-730 | ASTM
D5151-06
(Reapproved
2011) | | | | | | |
| Dimensions
Length (mm) | 240-247 | 240-248 | 241-247 | 244-252 | 240-247 | 247-253 | 245-253 | 245-253 | 240-251 | | | | | | | |
| Dimensions
Width (mm) | 95-97 | 97-99 | 95-97 | 95-99 | 95-97 | 96-97 | 96-99 | 96-98 | 94-96 | Detection of
Holes in
Medical
Gloves | | | | | | |
| Thickness
Finger (mm) | 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 | 0.15-0.19 | | | | | | | |
| Thickness Palm
(mm) | 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 | 0.12-
0.16 | | | | | | | |
| AQL (As per
FDA
requirement) | Multiple
Normal
Samplin
g
GII
AQL
2.5
Lot size:
16,000
Sample
Size: 80
Acc: 5
Rej: 6
Result:
0 | Multiple
Normal
Samplin
g
GII
AQL
2.5
Lot size:
16,000
Sample
Size: 80
Acc: 5
Rej: 6
Result:
0 | Multiple
Normal
Samplin
g
GII
AQL
2.5
Lot size:
16,000
Sample
Size: 80
Acc: 5
Rej: 6
Result:
0 | Multiple
Normal
Samplin
g
GII
AQL
2.5
Lot size:
16,000
Sample
Size: 80
Acc: 5
Rej: 6
Result:
0 | Multiple
Normal
Samplin
g
GII
AQL
2.5
Lot size:
16,000
Sample
Size: 80
Acc: 5
Rej: 6
Result:
0 | Multiple
Normal
Samplin
g
GII
AQL
2.5
Lot size:
16,000
Sample
Size: 80
Acc: 5
Rej: 6
Result:
0 | Multiple
Normal
Samplin
g
GII
AQL
2.5
Lot size:
16,000
Sample
Size: 80
Acc: 5
Rej: 6
Result:
0 | Multiple
Normal
Samplin
g
GII
AQL
2.5
Lot size:
16,000
Sample
Size: 80
Acc: 5
Rej: 6
Result:
0 | Multiple
Normal
Sampling
GII
AQL 2.5
Lot size:
16,000
Sample
Size: 80
Acc: 5
Rej: 6
Result: 0 | | | | | | | |
| Residual
Powder
(mg/glove) | 0.99%
Average | 1.1%
Avg. | 1.0%
Avg. | 1.0%
Avg. | 1.2%
Avg. | 1.1%
Avg. | 0.8%
Avg. | 1.0%
Avg. | 0.20%
Avg. | | | | | | | |
| Size | M | M | M | M | M | M | M | M | M | | | | | | | |
8
| Characteristics | Blue
Glove
8603F
(AD) | Blue
Glove
8611F
(M) | Blue
Glove
8603F
(Y4) | Blue
Glove
8613F | K142283
Blue
Glove
8603 (H) | Blue
Glove
8612F
(C ) | Black
Gloves
8604T | White
Gloves
8617F | Predicate
K052502 | Medical
Glove
Manual
(1661) |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Biocompatibility | Under
the
conditio
n of the
study the
device is
non-
irritant
and non-
sensitize
r | Under
the
conditio
n of the
study
the
device
is non-
irritant
and
non-
sensitiz
er | Under
the
condit
ion of
the
study
the
device
is
non-
irritant
and
non-
sensiti
zer | Under
the
condit
ion of
the
study
the
device
is
non-
irritant
and
non-
sensiti
zer | Under
the
conditio
n of the
study the
device is
non-
irritant
and non-
sensitize
r | Under
the
conditio
n of the
study the
device is
non-
irritant
and non-
sensitize
r | Under
the
condition
of the
study the
device is
non-
irritant
and non-
sensitizer | Under
the
conditio
n of the
study
the
device is
non-
irritant
and non-
sensitize
r | Non-irritant
Non-sensitizer | ISO 10993-10
Skin Irritant
Dermal and
Sensitization
studies |
| Labeling for
legally
marketed
predicate | | | | | | | | | -Powder Free
-devices
color:
Clear(Blue)
-Patient
Examination
Glove
-Non sterile
-Single Use
Only
Manufactured
For:
- Lot | Chapter 4 -
Labeling |
9.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for substantial equivalent discussion
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 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] have the above technological characteristic compared to ASTM or Equivalent standards.
10.0 Conclusion
The conclusions drawn from the non-clinical tests demonstrate that 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] and the predicate device is substantially equivalent based on intended uses, physical properties, technological characteristics and nonclinical performance. This device is safe, effective, and performs as well as the predicate device.