(413 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterility of a surgical glove, with no mention of AI or ML technologies.
No.
The device (surgical gloves) is intended to protect a surgical wound from contamination, not to treat or directly affect a disease or condition in a therapeutic manner.
No
The device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a surgical glove made of natural rubber latex, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination." This describes a barrier device used during surgery.
- Device Description: The description details a surgical glove made of natural rubber latex.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for testing purposes.
The device is clearly a medical device, specifically a surgical glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber; intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
The subject device is a surgical glove made of natural rubber latex compound. It is sterile, Powder free. The device is anatomic and is hand specific. The device meets ASTM D3577 – 09 : Standard specification for Rubber Surgical Gloves. 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing demonstrated that the device meets standards for:
- Freedom from Holes (ASTM D3577-09 / ASTM D5151-06) - Meets
- Dimensions (ASTM D3577-09) - Meets
- Physical Properties (ASTM D3577-09 / ASTM D412-06) - Meets
- Powder-free residue (ASTM D6124-06) - Meets
- Bio-compatibility (Primary skin irritation - ISO 10993-10, Skin Sensitization - ISO 10993-10) - Non-irritant, Non-sensitizer
- Expiration dating/Shelf life (ASTM D7160-05) - Three years
- Sterilization (ISO 11135-2014(E)) - Meets
- EO Residue (ISO 10993-07:2008) - Meets
- ECH Residue (ISO 10993-07:2008) - Meets
- Sterility (ISO 11737 -2) - Sterile
Performance data based on ASTM D3577-09 and FDA 1000ml water leak test:
- Freedom from Pin holes: FDA 1000 ml water leak test, ASTM D5151 -06 (Re-approved 2011), ISO 2859-1 / G1/AQL 2.5, PASS
- Dimensions (Length): ASTM D3577 -09, ISO 2859-1 / S2/AQL 4.0, > 265 mm, PASS
- Dimensions (Width): ASTM D3577-09, ISO 2859-1 / S2/AQL 4.0, 76±6 mm to 114±6 mm (sizes 6.0 to 9.0), PASS
- Dimensions (Thickness): ASTM D3577-09, ISO 2859-1 / S2/AQL 4.0, > 0.10 mm (Cuff, palm & finger), PASS
- Physical properties (Before aging): ASTM D3577-09 and ASTM D412-06, ISO 2859-1 / S2/AQL 4.0, Tensile strength : > 24 Mpa, Ultimate Elongation : >750%, PASS
- Physical properties (After Accelerated aging): ASTM D3577-09 and ASTM D573-04, ISO 2859-1 / S2/AQL 4.0, Tensile strength : > 18 Mpa, Ultimate Elongation : > 560%, PASS
- Powder-free residue: ASTM D3577-09 and ASTM D6124-06, N=5, Less than 2 mg per glove, PASS
- Biocompatibility (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: ISO-11737-2, Sterile, PASS
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
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
July 13, 2018
Sanrea Healthcare Products Pvt Ltd Jose M Manager QA & RA Plot #P-56, Pearl Road Kinfra IIT Park, Kanjikode Palakkad, 678 621 In
Re: K171550
Trade/Device Name: Sterile Latex Surgical Gloves, Powderfree Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: June 8, 2018 Received: June 12, 2018
Dear Jose M:
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 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.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elizabeth F. Claverie -S
For Tina Kiang, Ph.D. 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) K171550
Device Name
STERILE LATEX SURGICAL GLOVES, POWDER FREE
Indications for Use (Describe)
The Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber; intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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 | ||
| 3.0 PREPARATION DATE | : | 05TH July 2018 |
IDENTIFICATION OF THE SUBJECT DEVICE 4.0
4
| 4.1 Device Name | : STERILE LATEX SURGICAL GLOVES, POWDER FREE |
|---|---|
| 4.2 Trade Name | : SANCARE STERILE LATEX SURGICAL GLOVES, |
| GLOVTEK STERILE LATEX SURGICAL GLOVES | |
| 4.3 Common Name | : SURGEON'S GLOVES |
| 4.4 Classification | : SURGEON'S GLOVES |
| 4.5 Class | : CLASS I |
| 4.6 CFR Regulation Number | : 21 CFR 878.4460 |
| 4.7 Product Code | : KGO |
5.0 IDENTIFICATION OF LEGALLY MARKETED PREDICATE DEVICE
| 5.1 Device Name | : | Powder free Sterile Latex Surgical Gloves, Yellow Color |
|---|---|---|
| 5.2 510(k) Number | : | K140988 |
| 5.3 Company | : | M/S. Hebei HongSen Plastic Technology Co. Ltd |
| 853 Dorchester Ln Unitb | ||
| New Milford, NJ 07646 | ||
| 5.4 Device Description | : | Powder free Sterile Latex Surgical Gloves, Yellow Color |
| 5.5 Classification | : | SURGEON'S GLOVES |
| 5.6 Class | : | CLASS I |
| 5.7 CFR Regulation Number | : | 21 CFR 878.4460 |
| 5.8 Product Code | : | KGO |
| 5.9 Classification Panel | : | General Hospital |
5
DESCRIPTION OF THE DEVICE 6.0
The subject device is a surgical glove made of natural rubber latex compound. It is sterile, Powder free. The device is anatomic and is hand specific. The device meets ASTM D3577 – 09 : Standard specification for Rubber Surgical Gloves. The device is for over-the counter single use.
7.0 INDICATIONS FOR USE
The Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber, intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.
8.0 TECHNOLOGICAL CHARACTERISTICS COMPARISON
| Characteristics | PREDICATE - 510(K) :
K140988 | SUBJECT DEVICE : | Comparison | |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Manufacturer | M/S. Hebei HongSen Plastic
Technology Co. Ltd
853 Dorchester Ln Unitb
New Milford, NJ 07646 | SANREA HEALTHCARE
PRODUCTS PVT LTD. Plot # P-
56, Pearl Road, Kinfra Integrated
Industrial & Textile Park,
Kanjikode, Palakkad, Kerala, India
- 678 621 | - | |
| Product Name | Powder free Sterile Latex
Surgical Gloves, Yellow Color | Sterile Latex Surgical Gloves,
Powder free | Similar | |
| Intended Use | Intended to be worn by
operating room personnel to
protect a surgical wound from
contamination. | Intended for medical purposes
that is worn by operating room
personnel to protect a surgical
wound from contamination. | Same | |
| Indication for
use | The powder free sterile latex
surgical glove, yellow color
(Brand Name: Titanfine), is a
disposable device made of | The Sterile Latex Surgical
Gloves, Powder free, is a
disposable device made of
natural rubber, intended for | Similar | |
| | natural rubber intended to be
worn by operating room
personnel to protect a surgical
wound from contamination. | medical purposes that is worn by
operating room personnel to
protect a surgical wound from
contamination. | | |
| Description | Sterile Powder free, surgical
gloves are made of natural
rubber latex. The gloves are
provided in Sizes 6.0, 6.5, 7.0,
7.5, 8.0, 8.5 and 9.0 | Sterile Powder free , surgical
gloves are made of natural rubber
latex. The gloves are provided in
Sizes 6.0, 6.5, 7.0, 7.5, 8.0, 8.5
and 9.0 | Same | |
| Presentation | Sterile gloves are provided in
pouches | Sterile gloves are provided in
pouches | Similar | |
| Material | Natural Rubber Latex | Natural Rubber Latex | Same | |
| Color | Yellow Color | Natural (No color is added) | Different | |
| Non-sterile or
sterile | Sterile | Sterile | Same | |
| Single Use | Yes | Yes | Same | |
| Anatomic | Yes | Yes | Same | |
| Dimensions | Meets ASTM D3577-09 -
Overall length min 265 mm
,width varies from 76 mm for
6.0 size to 114 mm for 9.0 size,
thickness in cuff, finger and
palm has a minimum 0.10mm | Meets ASTM D3577 - 09
Dimension for size 7.5 :
Length : 300mm
Width : 95mm
Thickness - Cuff : 0.14mm, Palm :
0.19mm, Finger : 0.22mm | Similar | |
| Tensile
Strength | Meets ASTM D3577 -09 and
ASTM D412, D573. Tensile
strength 24 Mpa min for before
aging and 18 Mpa min for after
aging. Aging done at 70 $\pm$ 2 deg
C for 166 $\pm$ 2 hrs or 100 $\pm$ 2deg C | Meets ASTM D3577 -09 and
ASTM D412, D573.
Results for size 7.5 :
Tensile strength
(Before Ageing): 31.22 MPa
Tensile strength | Similar | |
| | for 22±0.3 hrs | (After Ageing): 24.43 MPa | | |
| Ultimate
Elongation | Meets ASTM D 3577-09 -
Ultimate elongation 750% min
for before aging and 560 % min
for after aging. Aging done at
70 ±2 deg C for 166±2 hrs or
100±2deg C for 22±0.3hrs | Meets ASTM D 3577-09 Results
for size 7.5 :
Ultimate Elongation
(Before Ageing) : 843.09 %
Ultimate Elongation
(After Ageing) : 762.28 % | Similar | |
| | Freedom from
pinholes | Meets ASTM D 5151 -06 and
ASTM D3577 – 09 | Meets ASTM D 5151 -06 (2011)
and ASTM D3577- 09
Results for size 7.5 :
Inspection level/AQL :
ISO 2859-1 / G1 / AQL 1.5
Lot Size : 35001 – 150000 pair
Sample size : 200 pair
Holes found : 0 holes
Accept/Reject : 10/11 | Similar |
| | Residual Powder
Content | Meets ASTM D 6124-06(2011) | Meets ASTM D 6124-06(2011)
Result for size 7.5 :
Powder content : 0.9mg/glove | Similar |
| | Residual
Protein Content | Meets ASTM D 5712 | Meets ASTM D 5712
Result for size 7.5 :
Protein Content : 25.56 µg/ dm2 | Similar |
| | Biocompatibility
Tests -
ISO 10993-10 | Under the conditions of the
study the device is not an
irritant | Under the conditions of the study
the device is not an irritant | Same |
| Under the conditions of the
study the device is not a
sensitizer | | Under the conditions of the study
the device is not a sensitizer | Same | |
| Sterility | Sterile | Sterile | Same | |
| Mode of
Sterilization | Irradiation | EO Sterilization | Different | |
| Labeling | * Powder free
- Latex Surgical Glove
- Sterile
- Single use only | * Powder free
- Latex Surgical Glove
- Sterile
- Single use only | Identical | |
6
7
8
| * Anatomic | * Anatomic |
|---|---|
| * Manufactured for | * Manufactured for |
| * Lot No | * Lot No |
| * Intended use | * Intended use |
| * Quantity | * Quantity |
| * Country of origin | * Country of origin |
The above table shows similarities and differences of the performance between the subject device and the predicate device. There are only two minor differences between the subject device and the predicate device. One of the differences is that the predicate device has yellow color, while our device in submission is natural in color. The second difference is that the subject device is sterilized by EO sterilization where as the predicate device is sterilized by irradiation method. These minor differences do not impact the intended use, safety and performance of the device.
SUMMARY OF NON-CLINICAL TESTING 9.0
There is no difference in technological characteristics compared to the predicate device.
Gloves are made from Latex compound, which is Sterile and Powder free. The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below,
| Characteristics | Standards | Performance of
Sterile Latex Surgical
Gloves, Powder free |
|----------------------------------|----------------------------------------|-----------------------------------------------------------------|
| Freedom from
Holes | ASTM D3577-09 / ASTM D5151-06 | Meets |
| Dimensions | ASTM D3577-09 | Meets |
| Physical Properties | ASTM D3577-09 / ASTM D412-06 | Meets |
| Powder-free
residue | ASTM D6124-06 | 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) | Meets |
9
| | Sterilization of healthcare products - Ethylene
Oxide - Requirements for the development,
validation and routine control of a sterilization
process for medical devices | |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | ISO 10993-07:2008
Biological evaluation of medical devices- Part 7:
Ethylene oxide sterilization residuals
Maximum limit of EO Residue :
0.0025mg/device | Meets |
| EO Residue | | |
| | ISO 10993-07:2008
Biological evaluation of medical devices- Part 7:
Ethylene oxide sterilization residuals
Maximum limit of ECH Residue :
0.0025mg/device | Meets |
| ECH Residue | | |
| | 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 |
| Sterility | | |
Performance data of gloves based on ASTM D3577-09 and FDA 1000ml water leak test
| ASTM D3577 - 09 and FDA 1000 ml water leak test | |||||
|---|---|---|---|---|---|
| Characteristics | Test | Test standard | Sampling plan | ||
| /Inspection | |||||
| level / AQL | Sterile Latex | ||||
| Surgical Gloves, | |||||
| Powder free | Result | ||||
| Freedom from | |||||
| Pin holes | FDA 1000 ml | ||||
| water leak | |||||
| test | ASTM D5151 -06 | ||||
| (Re-approved 2011) | ISO 2859-1 / | ||||
| G1/AQL 2.5 | PASS | PASS | |||
| Length | ASTM D3577 -09 | ISO 2859-1 / | |||
| S2/AQL 4.0 | > 265 mm | PASS |
10
| Dimensions | Width | ASTM D3577-09 | ISO 2859-1 /
S2/AQL 4.0 | 76±6 mm to 114±6
mm (sizes 6.0 to 9.0) | PASS |
|------------------------|-------------------------------|------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------|------|
| | Thickness | ASTM D3577-09 | ISO 2859-1 /
S2/AQL 4.0 | > 0.10 mm
(Cuff, palm&
finger) | PASS |
| Physical
properties | Before aging | ASTM D3577-09
and ASTM D412-06 | ISO 2859-1 /
S2/AQL 4.0 | Tensile strength :
24 Mpa | PASS |
| | | | | Ultimate Elongation
: >750% | PASS |
| | After
Accelerated
aging | ASTM D3577-09
and ASTM D573-04 | ISO 2859-1 /
S2/AQL 4.0 | Tensile strength :
18 Mpa
Ultimate Elongation
: > 560% | PASS |
| Powder-free
residue | Powder-free
residue | ASTM D3577-09 and
ASTM D6124-06 | N=5 | Less than 2 mg per
glove | PASS |
| Biocompatibility | Primary skin
irritation | ISO 10993 -10 | Under the conditions of the study the
device is not an irritant | | PASS |
| | Skin
Sensitization | ISO 10993 -10 | Under the conditions of the study the
device is not a sensitizer | | PASS |
| Sterility | Sterility | ISO-11737-2 | Sterile | | PASS |
10.0 CONCLUSION
Based on the intended use, physical properties and technological characteristics, the subject device is as safe, as effective and performs as well as the legally marketed predicate device.