(98 days)
Not Found
No
The device is a simple examination glove and the summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is a patient examination glove used to prevent contamination, not to treat or directly manage a medical condition.
No
The device description clearly states it is for "medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner," indicating it is a barrier device for protection, not a tool for diagnosing medical conditions.
No
The device is a physical glove made of nitrile latex, not software. The description focuses on material properties and physical performance tests.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gloves are "worn on the examiners' hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the material, sterility, and physical properties of the glove. There is no mention of any components or mechanisms for analyzing biological samples or providing diagnostic information.
- Performance Studies and Key Metrics: The performance studies and key metrics evaluate the physical integrity, biocompatibility, and sterility of the glove. These are relevant to its function as a barrier, not as a diagnostic tool.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does none of that.
This device is a medical device, specifically a patient examination glove, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Sterile Nitrile Patient Examination gloves, Powder free, Blue color, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The subject device is a patient examination glove made of synthetic nitrile latex compound. It is sterile, Powder free and is Blue in colour. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D6319-10: Standard specification for Nitrile Examination Gloves for Medical Application. The subject device is substantially equivalent to legally marketed Nitrile examination gloves identified as Product code LZA. The 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
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)
There is no difference in technological characteristics compared to the predicate device. Gloves are made from Nitrile latex compound, Sterile, Powder free and Blue in color. The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below,
Freedom from Holes: Meets (ASTM D6319-10 / ASTM D5151-06)
Dimensions: Meets (ASTM D6319-10)
Physical Properties: Meets (ASTM D6319-10 / ASTM D412-06)
Powder free residue: Meets (ASTM D6319-10)
Bio-compatibility: Non-irritant (Primary skin irritation ISO 10993-10), Non-sensitizer (Skin Sensitization ISO 10993-10)
Expiration dating/Shelf life: Three years (ASTM D7160-05)
Sterilization: Meets (ISO 11135-2014(E))
Sterility: Sterile (ISO 11737 -2)
Performance data of gloves based on ASTM D6319-10 and FDA 1000ml water leak test:
Freedom from Pin holes: PASS (FDA 1000 ml water leak test, ASTM D5151 -06 (Reapproved 2011), ISO 2859-1 / G1/AQL 2.5)
Dimensions (Length): PASS (> 230 mm, ASTM D6319 -10, ISO 2859-1 / S2/AQL 4.0)
Dimensions (Width): PASS (70±10 mm to 120±10 mm (sizes XS to XL), ASTM D6319 -10, ISO 2859-1 / S2/AQL 4.0)
Physical properties (Thickness): PASS (> 0.05 mm (palm & finger), ASTM D6319 -10, ISO 2859-1 / S2/AQL 4.0)
Physical properties (Before aging): PASS (Tensile strength : > 14 Mpa Ultimate Elongation : >500%, ASTM D6319 -10 and ASTM D412-06, ISO 2859-1 / S2/AQL 4.0)
Physical properties (After Accelerated aging): PASS (Tensile strength : > 14 Mpa Ultimate Elongation : > 400 %, ASTM D6319 -10 and ASTM D412-06, ISO 2859-1 / S2/AQL 4.0)
Powder free residue: PASS (Less than 2 mg per glove, ASTM D6319 -10 and ASTM D6124-06, N=5)
Biocompatibility (Primary skin irritation): PASS (Under the conditions of the study the device is not an irritant, ISO 10993 -10)
Biocompatibility (Skin Sensitization): PASS (Under the conditions of the study the device is not a sensitizer, ISO 10993 -10)
Sterility: Sterile (Sterility, ISO-11737-2)
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.
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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2017
Sanrea Healthcare Products Pvt Ltd Jose M. Paul Manager Oa & RA Plot #P-56, Pearl Road Kinfra IIT Park, Kanjikode Palakkad, 678 621 In
Re: K171093
Trade/Device Name: Sterile Nitrile Patient Examination Gloves, Powder free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: July 23, 2017 Received: April 12, 2017
Dear Jose M. Paul:
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.
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
1
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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Tara A. Ryan -S
for Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171093
Device Name
STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDER FREE, BLUE COLOUR
Indications for Use (Describe)
The Sterile Nitrile Patient Examination gloves, Powder free, Blue color, is a disposable device intended for medical purposes that is worn on the examiners' 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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1.0 SUBMITTER
| 1.1 Company Name | : | SANREA HEALTHCARE PRODUCTS PVT LTD |
|---|---|---|
| 1.2 Address | : | Plot#P-56, Pearl Road, Kinfra Integrated Industrial & |
| Textile Park, Kanjikode, Palakkad | ||
| Kerala, India– 678 621 | ||
| 1.3 Telephone | : | + 91-491 -2970145 |
| 1.4 Email | : | josepaul@primusgloves.com, sanreaqa@gmail.com, |
| qa@sanrea.com | ||
| 1.5 Contact Person | : | Mr. JOSE PAUL M |
| MANAGER QA & RA |
2.0 OFFICIAL CORRESPONDENT
| 2.1 Company Name | : | SANREA HEALTHCARE PRODUCTS PVT LTD |
|---|---|---|
| 2.2 Address | : | Plot#P-56, Pearl Road, Kinfra Integrated Industrial & |
| Textile Park, Kanjikode, Palakkad | ||
| Kerala, India– 678 621 | ||
| 2.3 Telephone | : | +91-491-2970145 |
| 2.4 Email | : | josepaul@primusgloves.com, sanreaqa@gmail.com, |
| qa@sanrea.com | ||
| 2.5 Contact Person | : | Mr. JOSE PAUL M |
| MANAGER QA & RA |
4
PREPARATION DATE 3.0
4.0 NAME OF THE DEVICE
| 4.1 Device Name | : | STERILE NITRILE PATIENT EXAMINATION
GLOVES, POWDER FREE, BLUE COLOUR |
|--------------------|---|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4.2 Trade Name | : | * SANCARE STERILE NITRILE PATIENT EXAMINATION
GLOVES POWDER FREE. BLUE COLOUR
- GLOVTEK STERILE NITRILE PATIENT EXAMINATION
GLOVES POWDER FREE, BLUE COLOUR |
| 4.3 Common Name | : | PATIENT EXAMINATION GLOVES |
| 4.4 Classification | : | PATIENT EXAMINATION GLOVES |
| 4.5 Class | : | CLASS I |
| 4.6 Product Code | : | LZA |
IDENTIFICATION OF LEGALLY MARKETED PREDICATE DEVICE 5.0
| 5.1 Device Name | : | Sterile Nitrile Powder free Examination Glove (VBLU) |
|---|---|---|
| 5.2 510(k) Number | : | K132006 |
| 5.3 Company | : | HARTALEGA SDN BHD, # 7, Kawasan, Perusahaan Suria, |
| Batang Berjuntai, Selangor, Darul Ehsan, MY 45600 | ||
| 5.4 Device Description | : | Sterile Nitrile Powder free Examination Glove(VBLU) |
| 5.5 Classification | : | PATIENT EXAMINATION GLOVES |
| 5.6 Class | : | CLASS I |
| 5.7 Product Code | : | LZA |
| 5.8 Classification Panel | : | General Hospital |
5
6.0 DESCRIPTION OF THE DEVICE
The subject device is a patient examination glove made of synthetic nitrile latex compound. It is sterile, Powder free and is Blue in colour. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D6319-10: Standard specification for Nitrile Examination Gloves for Medical Application. The subject device is substantially equivalent to legally marketed Nitrile examination gloves identified as Product code LZA. The device is for over-the counter single use.
7.0 INDICATIONS FOR USE
The Sterile Nitrile Patient Examination gloves, Powder free., Blue color, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
8.0 SUMMARY OF PERFORMANCE DATA
There is no difference in technological characteristics compared to the predicate device. Gloves are made from Nitrile latex compound, Sterile, Powder free and Blue in color. The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below,
| Characteristics | Standards | Performance of Nitrile
patient examination
gloves, Powder free,
Blue color |
|---------------------|----------------------------------|-------------------------------------------------------------------------------------|
| Freedom from Holes | ASTM D6319-10 / ASTM
D5151-06 | Meets |
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 / ASTM
D412-06 | Meets |
6
| Powder free residue | ASTM D6319-10 | Meets |
|---|---|---|
| Bio-compatibility | Primary skin irritation | |
| ISO 10993-10 | Non-irritant | |
| Skin Sensitization | ||
| ISO 10993-10 | Non-sensitizer | |
| Expiration | ||
| dating/Shelf life | ASTM D7160-05 | Three years |
| Sterilization | ISO 11135-2014(E) | |
| Sterilization of healthcare | ||
| products - Ethylene Oxide - | ||
| Requirements for the | ||
| development, validation and | ||
| routiene control of a sterilization | ||
| process for medical devices | Meets | |
| Sterility | ISO 11737 -2 | |
| Sterilization of Medical devices- | ||
| Microbiological methods Part 2: | ||
| Test of sterility performed in the | ||
| definition , validation and | ||
| maintenance of sterilization | ||
| process | Sterile | |
Performance data of gloves based on ASTM D6319-10 and FDA 1000ml water leak test
| ASTM D6319-10 and FDA 1000 ml water leak test | |||||
|---|---|---|---|---|---|
| Characteristics | Test | Test standard | Sampling plan / | ||
| Inspection level / AQL | Sterile, Powder free, | ||||
| Nitrile Examination | |||||
| Gloves- SANCARE | RESULT | ||||
| Freedom from | |||||
| Pin holes | FDA 1000 ml water | ||||
| leak test | ASTM D5151 -06 | ||||
| (Reapproved 2011) | ISO 2859-1 / | ||||
| G1/AQL 2.5 | PASS | PASS | |||
| Dimensions | Length | ASTM D6319 -10 | ISO 2859-1 / | ||
| S2/AQL 4.0 | > 230 mm | PASS | |||
| Width | ASTM D6319 -10 | ISO 2859-1 / | |||
| S2/AQL 4.0 | 70±10 mm to | ||||
| 120±10 mm | PASS |
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| (sizes XS to XL) | |||||
|---|---|---|---|---|---|
| Physical | |||||
| properties | Thickness | ASTM D6319 -10 | ISO 2859-1 / | ||
| S2/AQL 4.0 | > 0.05 mm | ||||
| (palm & finger) | PASS | ||||
| Before aging | ASTM D6319 -10 | ||||
| and ASTM D412-06 | ISO 2859-1 / | ||||
| S2/AQL 4.0 | Tensile strength : |
14 Mpa
Ultimate Elongation
: >500% | PASS |
| | After
Accelerated
aging | ASTM D6319 -10
and ASTM D412-06 | ISO 2859-1 /
S2/AQL 4.0 | Tensile strength :
14 Mpa
Ultimate Elongation
: > 400 % | PASS |
| Powder free
residue | Powder free
residue | ASTM D6319 -10
and ASTM D6124-06 | N=5 | Less than 2 mg per
glove | PASS |
| | Primary skin
irritation | ISO 10993 -10 | Under the conditions of the study
the device is not an irritant | | PASS |
| Biocompatibility | Skin
Sensitization | ISO 10993 -10 | Under the conditions of the study
the device is not a sensitizer | | PASS |
| | Sterility | Sterility | ISO-11737-2 | Sterile | |
9.0 Summary of the technological characteristics of device compared to the legally marketed predicate device
| Characteristics | PREDICATE – 510(K) :
K132006 | SUBJECT DEVICE :
K171093 | Acceptance
criteria/Standard |
|-----------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Manufacturer | HARTALEGA SDN BHD, #
7, Kawasan, Perusahaan
Suria,
Batang Berjuntai, Selangor,
Darul Ehsan, MY 45600 | SANREA HEALTHCARE
PRODUCTS PVT LTD. Plot #
P-56, Pearl Road, Kinfra
Integrated Industrial & Textile
Park, Kanjikode, Palakkad,
Kerala, India – 678 621 | - |
8
| Product Name | Sterile Nitrile Powder free | Sterile Nitrile Patient | Patient examination |
|---|---|---|---|
| Examination Glove(VBLU) | Examination Gloves, Powder | ||
| free, Blue color | gloves | ||
| Intended Use | Intended for medical purpose | Intended for medical purpose | Medical Glove |
| that is worn on the | that is worn on the Examiners | Guidance Manual | |
| Examiners hand or finger to | hand or finger to prevent | ||
| prevent contamination | contamination between | ||
| between patient and | patient and examiner | ||
| examiner | |||
| Indication for use | The examination gloves is a | The Sterile Nitrile Patient | Medical Glove |
| disposable device intended | Examination gloves, Powder | Guidance Manual | |
| for medical purposes that is | free., Blue color, is a | ||
| worn on the examiners hand | disposable device intended | ||
| or finger to prevent | for medical purposes that is | ||
| contamination between | worn on the examiners' hand | ||
| patient and examiner | or finger to prevent | ||
| contamination between | |||
| patient and examiner. | |||
| Description | Sterile Powder free, | Sterile Powder free , | Medical Glove |
| examination gloves made of | examination gloves made of | Guidance Manual | |
| nitrile and colored blue. The | nitrile and colored blue. The | ||
| gloves are provided in Sizes | gloves are provided in Sizes | ||
| Extra Small, Small, Medium, | Extra Small, Small, Medium, | ||
| Large and Extra Large | Large and Extra Large | ||
| Presentation | Sterile gloves are provided in | Sterile gloves are provided in | Medical Glove |
| pouches | pouches | Guidance Manual | |
| Material | Nitrile synthetic latex | Nitrile synthetic latex | ASTM D6319-10 |
| LZA product code | |||
| Non-sterile or | Sterile | Sterile | Sterility |
| sterile | |||
| Single Use | Yes | Yes | Disposable / |
| Single use | |||
| Ambidextrous | Yes | Yes | ASTM D 6319-0 |
| Overall length min 240 mm | Meets ASTM D | ||
| Dimensions | Meets ASTM D 6319-10 | ,width varies from 70 mm for | |
| XS size to 120 mm for XL | |||
| size, thickness in finger and | |||
| palm has a minimum 0.05 mm | 6319-10 |
- Overall length min
240 mm, width
varies from 70 mm
for XS size to 120
mm for XL size,
thickness in finger
and palm has a
minimum 0.05 mm |
| Tensile Strength | Meets ASTM D 6319-10 | Tensile strength 14 Mpa min
for before aging and 14 Mpa
min for after aging
Aging done at 70 ±2 deg C
for 166±2 hrs or 100±2deg C
for 22±0.3 hrs | Meets ASTM D
6319-10- Tensile
strength 14 Mpa min
for before aging and
14 Mpa min for after
aging |
| Ultimate
Elongation | Meets ASTM D 6319-10 | Ultimate elongation 500 %
min for before aging and 400
% min for after aging. Aging
done at 70 ±2 deg C for
166±2 hrs or 100±2deg C for
22±0.3 hrs | Meets ASTM D
6319-10 - Ultimate
elongation 500 %
min for before aging
and 400 % min for
after aging. Aging
done at 70 ±2 deg C
for 166±2 hrs or
100±2deg C for
22±0.3 hrs |
| Freedom from
pinholes | Meets ASTM D 5151 -06
and ASTM D6319-10 | Meets ASTM D 5151 -06
(2011) and ASTM D6319-10 | ASTM D 5151 -06
(2011) and ASTM
D6319-10 |
| Residual Powder | Meets ASTM D 6124-06 | Less than 2 mg per glove | ASTM D 6124-
06(2011) : Less than
2 mg per glove |
| Biocompatibility
Tests | Non-irritant -Primary Skin
Irritation In Rabbits | Under the conditions of the
study the device is not an
irritant | Under the conditions
of the study the
device is not an
irritant |
| ISO 10993-10 | Non-sensitizer - skin
Sensitization in Guinea pigs | Under the conditions of the
study the device is not a
sensitizer | Under the conditions
of the study the
device is not a
sensitizer |
| Sterility | Sterile | Sterile | Meets ISO 11737-02 |
| Labeling | * Powder free,
- Nitrile patient exam glove
- Sterile
- Single use only
- Ambidextrous
- Blue color
- Manufactured for
- Lot No
- Intended use
- Quantity
- Country of origin | * Powder free,
- Nitrile Patient exam glove
- Sterile
- Single use only
- Ambidextrous
- Blue color
- Manufactured for
- Lot No
- Intended use
- Quantity
- Country of origin | Chapter 4 - Labeling
- Medical Glove
Guidance Manual |
9
10
10.0 CONCLUSION
The conclusions drawn from the non clinical tests of the subject device K171093(Sterile Nitrile Patient Examination Gloves, Powder free., Blue color) demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device identified as Sterile Nitrile Powder free Examination Glove (VBLU), cleared under K132006.