(226 days)
No
The device description and performance studies focus on the physical properties and sterility of a latex surgeon's glove, with no mention of AI or ML.
No
The device is a surgeon's glove, which is intended to protect a surgical wound from contamination, not to treat or cure a disease or condition.
No
Explanation: The device described is a latex surgeon's glove, which is a protective barrier intended to prevent contamination during surgery. It does not perform any diagnostic function.
No
The device description clearly states it is a physical product (latex surgeon's gloves) and describes its material, sterilization method, and physical properties. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination by being worn by operating room personnel. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The description focuses on the physical properties, materials, and sterilization of a glove. It does not mention any reagents, assays, or procedures for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
Therefore, this device is 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
A latex surgeon's glove is a device made of natural rubber intended to be 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 proposed device, Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound fromcontamination.
The proposed device is made of' natural rubber latex, as per standard ASTM D35 77-09(2015).
The classification is: Type I - gloves compounded primarily from natural rubber latex".
The proposed device is Powder Free Latex Surgeon's Gloves, and variants of different sizes.
All variants share the same color, creamy, white.
The proposed device is sterilized either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 6and place in a sterility maintenance package to ensure a shelf life of 3 years.
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)
Bench tests were conducted to verify that the proposed device met all design specifications as the predicate devices. The standards used in this submission and the test results demonstrated that the proposed device complies with the following standards:
- ASTM D3577-09 (2015):- Standard Specification for Rubber Surgical Gloves.
- ASTM D 5151-06(2015):-Standard Test Method for Detection of Holes in . Medical Gloves.
- ASTM D6124-06(2017):-Standard Test Method for Residual Powder on . Medical Gloves.
- ASTM D5712-15:-Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
- ASTM D6499-18:-Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.
- ASTM F 1929-2015:-Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
- ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 11137-1-2006/ (R) 2010 validation of sterilization process.
- ISO 11137-2:2013, Sterilization of health care products - radiation - part 2: establishing the sterilization dose
- 1S01137-2:2013: Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose.
- ISO 10993-7:2008:-Biological evaluation of medical devices --: Ethylene oxide ● sterilization residuals.
- ISO 11135-1:2014 :- Sterilization of healthcare products -- Ethylene oxide -Part 1: Requirements for development, validation and routine control of a sterilization process for medicaldevices.
Key Results:
- Length: All sizes (5½ to 9) met the minimum 265mm specification, with an average value of 282mm.
- Width: All sizes met their specified width ranges (e.g., 70+/-6mm for Size 5½, 114+/-6mm for Size 9).
- Finger Thickness: Minimum 0.10mm, observed 0.20mm (Yes).
- Palm Thickness: Minimum 0.10mm, observed 0.16mm (Yes).
- Cuff Thickness: Minimum 0.10mm, observed 0.13mm (Yes).
- Tensile Strength (All sizes): Before aging: 24Mpa minimum, observed 26.5Mpa (Yes). After aging: 18Mpa minimum, observed 21.0Mpa (Yes).
- Ultimate Elongation (All sizes): Before aging: 750% minimum, observed 860% (Yes). After aging: 560% minimum, observed 725% (Yes).
- Stress at 500% before ageing (All sizes): 5.5 MPa Max, observed 2.6 Mpa (Yes).
- Pinhole AQL (All sizes): Before aging: Max 1.5, observed 1.0 (Yes). After aging: Max 1.5, observed 1.0 (Yes).
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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
October 24, 2019
Lenora Glove PVT LTD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Drive Ste 114 Aurora, Illinois 60504
Re: K190632
Trade/Device Name: Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50ug/dm2 or less per glove of extractable protein Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: September 18, 2019 Received: September 24, 2019
Dear Manoj Zacharias:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190632
Device Name
Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein
Indications for Use (Describe)
A latex surgeon's glove is a device made of natural rubber intended to be 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
LENORA GLOVE PVT.LTD. SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE
510K SUMMARY as required by: 21CFR § 807.92
A. APPLICANT INFORMATION
| 1. | Submitter Name | LENORA GLOVE PVT. LTD. |
|---|---|---|
| Date Submitted | September 18, 2019 | |
| Address | Plot No:15/104-1, Rottigoundanur, | |
| Thirumalayampalayam P.O., Coimbatore, | ||
| Tamilnadu State, India-641 105 | ||
| Phone | +91 422 2656 443, 2656 941 | |
| Fax | 1 (815) 986-2632 | |
| qa@lenoraglove.com | ||
| Contact Person | ANTONY KURIYAN | |
| Designation | Managing Director | |
| Contact Number | +91 974700797 | |
| Contact Email | qa@lenoraglove.com |
B. US AGENT & CONTACT PERSON INFORMATION
| US agent & contact person name | Manoj Zacharias |
|---|---|
| Address | Liberty Management Group Ltd. |
| 75 Executive Dr. STE 114, Aurora, IL- | |
| 60504, USA. | |
| Phone | (630) 270-2921 |
| Fax | (815) 986-2632 |
| manoj@libertymanagement.us |
C. DEVICE IDENTIFICATION
| Common Name | Surgeon's Glove |
|---|---|
| Device Name | Latex Surgeon's Glove powder free with |
| protein content labeling claim of 50 µg/dm² | |
| or less per glove of extractable protein | |
| Product proprietary or trade | |
| name | Latex Surgeon's Glove powder free with |
| protein content labeling claim of 50 µg/dm² | |
| or less per glove of extractable protein | |
| Classification name | Surgeon's Glove |
| Device Classification | 1 |
| Product Code | KGO |
| Regulation Number | 21 CFR 878.4460 |
| Review Panel | Gen & Plastic Surgery |
4
SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE
D.PREDICATE DEVICE INFORMATION
| Name of devices | 510k Number | 510K Owner | |
|---|---|---|---|
| Predicate device | “PRISTEEN” Latex Surgeon's | ||
| Glove powder free with | |||
| protein content labeling claim | |||
| of 50 $µg/dm^2$ or less per | |||
| glove of extractable protein | K172942 | Beta Health Care products | |
| Pvt.Ltd,Plot No 21B, | |||
| Cochin Special Economic | |||
| Zone,Kakkanad, kerala, | |||
| India-682037 | |||
| Reference device | “Medismart+” Latex Surgeon's | ||
| Glove powder free with | |||
| protein content labeling claim | |||
| of 50 $µg/dm^2$ or less per | |||
| glove of extractable protein | K151114 | St.Marys Rubbers Pvt.Ltd, | |
| Koovappally P.O, | |||
| Kanjirappally, Kottayam | |||
| District, Kerala State, | |||
| India-686518 |
E. DESCRIPTION OF THE DEVICE
The proposed device, Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound fromcontamination.
The proposed device is made of' natural rubber latex, as per standard ASTM D35 77-09(2015).
The classification is: Type I - gloves compounded primarily from natural rubber latex".
The proposed device is Powder Free Latex Surgeon's Gloves, and variants of different sizes.
All variants share the same color, creamy, white.
The proposed device is sterilized either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 6and place in a sterility maintenance package to ensure a shelf life of 3 years.
F. INDICATION FOR USE
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
5
SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE
G. TECHNOLOGICAL COMPARISON
a. General Characteristics Comparison
| Characteristic | Subject device
K190632 | Predicate device
K172942 | Reference device
K151114 | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | KGO | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Class | 1 | 1 | 1 | Same |
| Intended Use for
Latex Surgeon's
Gloves Powder
Free, with protein
content labeling
claim of
50µg/dm² or less
per glove of
extractable
protein. | A latex surgeon's glove is a
device made of natural
rubber intended to be worn
by operating room personnel
to protect a surgical wound
from contamination. | A latex surgeon
Surgeons glove is
a device made of
natural rubber
intended to be
worn by
operating room
personnel to
protect a surgical
wound from
contamination | A latex surgeon
Surgeons glove is
a device made of
natural rubber
intended to be
worn by
operating room
personnel to
protect a surgical
wound from
contamination | Similar |
| Powdered or
Powder free | Powder free | Powder free | Powder free | Same |
| Method of
powder free | Polymer coat | same | same | Same |
| Classification per
ASTMD3577-99 | Type I - gloves compounded
primarily from natural
rubber latex | Type I - gloves
compounded
primarily from
natural rubber
latex | Type I - gloves
compounded
primarily from
natural rubber
latex | Same |
| Sterilization | ETO/as well as Radiation,
SAL- 10-6 | ETO/as well as
Radiation,
SAL- 10-6 | ETO/as well as
Radiation,
SAL- 10-6 | Same |
| Label and
Labeling | Meet FDA's Requirements | Meet FDA's
Requirements | Meet FDA's
Requirements | Same |
| Special label
claim | Protein content labeling
claim of 50 µg/dm² or less
per glove of extractable
protein for Latex Surgeon's
Gloves Powder Free. | Same | Same | Same |
| Type of use | Over the counter use | Over the counter
use | Over the counter
use | Same |
6
SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE
| Characteristics | Acceptance criteria of the standard | |||
|---|---|---|---|---|
| Subject device | ||||
| K190632 | Predicate device | |||
| K172942 | Reference device | |||
| K151114 | Comparison | |||
| Dimensions | ASTM D3577- | |||
| 09((Reapproved 2015)) | ASTM D3577 | ASTM D3577 | Similar | |
| Physical | ||||
| Properties | ASTM D3577-09 | |||
| (Reapproved 2015) | ASTM D3577 | ASTM D3577 | Similar | |
| Freedom from | ||||
| Holes | ASTM D3577 and | |||
| AST MD5151-06, | ||||
| (Reapproved 2015) | ASTM D3577 and | |||
| AST M D5151 | ASTM D3577 and | |||
| AST M D5151 | Similar | |||
| Powder residue | ||||
| for powder free | ||||
| glove | ASTM D3577 and ASTM | |||
| D6124-06, (Reapproved |
Powder content