LYDUS Nitrile Examination Gloves, Powder Free
Device Facts
| Record ID | K203191 |
|---|---|
| Device Name | LYDUS Nitrile Examination Gloves, Powder Free |
| Applicant | Nathan Trading Co., Ltd. |
| Product Code | LZA · General Hospital |
| Decision Date | Feb 12, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
| Attributes | 3rd-Party Reviewed |
Intended Use
LYDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Device Story
Disposable, non-sterile, blue nitrile examination glove; worn on examiner's hands/fingers to provide barrier protection against contamination between patient and examiner. Used in clinical settings; operated by healthcare professionals or patients. Device acts as a physical barrier; prevents cross-contamination. Benefits include reduced risk of infection transmission during medical examinations.
Clinical Evidence
No clinical data. Bench testing only, including physical dimensions, tensile strength, elongation (before/after aging), freedom from holes (ASTM D5151), residual powder (ASTM D6124), and biocompatibility (ISO 10993-5, -10, -11).
Technological Characteristics
Nitrile compound; blue color; finger-textured; non-sterile; single-use. Dimensions and physical properties comply with ASTM D6319-19. Biocompatibility testing per ISO 10993 series. No software or electronic components.
Indications for Use
Indicated for use as a disposable medical glove worn on the examiner's hand or fingers to prevent contamination between patient and examiner. Suitable for use by clinicians and for over-the-counter use.
Regulatory Classification
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Predicate Devices
- Blue Nitrile Examination Gloves Powder Free (K192333)
Related Devices
- K211264 — Disposable Nitrile Examination Gloves · Shenzhen Shiqiao Science and Technology Co., Ltd. · Jul 30, 2021
- K042378 — NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE · Shijiazhuang Tillotson Rubber Products Co., Ltd. · Sep 20, 2004
- K210725 — Nitrile Patient Examination Glove · Pingan Medical Products Co., Ltd. · Aug 6, 2021
- K121526 — POWER-FREE NITRILE PATIENT EXAMINATION GLOVES · Shandong Junchi Medical Products Co., Ltd. · Aug 3, 2012
- K210691 — Disposable Nitrile Medical Examination Glove · Jiangsu Cureguard Glove Co., Ltd. · Jul 30, 2021
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
February 22, 2021
Nathan Trading Co., Ltd % Abdel Halim, PharmD, MSc, PhD, DABCC President Global Quality and Regulatory Services 10 Scenic Way Monroe, New Jersey 08831
Re: K203191
Trade/Device Name: LYDUS Nitrile Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA
Dear Abdel Halim:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 12, 2021. Specifically, FDA is updating this SE Letter as an administrative correct an incorrect contact name and an incorrect 510(k) number and contact name in the header.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ryan Ortega, OHT4: Office of Surgical and Infection Control Devices, 240-402-2303, Ryan.Ortega@fda.hhs.gov.
Sincerely,
Ryan Ortega -S
Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 12, 2021
Nathan Trading Co., Ltd % Abdel B. Halim, PharmD, MSc, PhD, DABCC Responsible Third-Party Official Global Quality and Regulatory Services 10 Scenic Way Monroe, NJ 08831
Re: K203191
Trade/Device Name: LYDUS Nitrile Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: January 26, 2021 Received: January 28, 2021
Dear Rafael Aguila:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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.
# Ryan Ortega -S
For CAPT. Elizabeth Claverie, M.S. Assistant Director 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
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#### Indications for Use
510(k) Number (if known)
K203191
Device Name
LYDUS Nitrile Examination Gloves, Powder Free
#### Indications for Use (Describe)
LYDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers 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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Image /page/4/Picture/0 description: The image is a circular logo for Nathan Trading Company Limited, or NTC. The logo has a green border with the word "NATHAN" at the top and "TRADING COMPANY LIMITED" at the bottom. There are two stars on either side of the word "NATHAN". In the center of the logo is the acronym "NTC" in bold, black letters.
NATHAN TRADING CO., LTD 58 Moo 12 Palan Sub-District, Nathan District, Ubon Ratchathani 34170 Thailand E-mail: csaiyasak@nathantrad.comTel.: +66818789953 Web: www.nathantrad.com
# 510(K) Summary K203191
## LYDUS NITRILE EXAMINATION GLOVES, POWDER FREE
Preparation Date: February 9, 2021
#### 1. SUBMITTER
Company Name: Nathan Trading Co., Ltd. Company Address: 58 Moo 12 Palan Sub-District, Nathan District, Ubon Ratchathani 34170 Thailand
Contact Person: Prof. Dr. Chansamone Saiyasak Telephone Number: +66-81-878-9953 Email: csaiyasak@nathantrad.com
#### 2. NAME OF THE DEVICE
Trade Name / Proprietary Name: LYDUS Nitrile Examination Gloves, Powder Free Device Name: LYDUS Nitrile Examination Gloves, Powder Free Device Classification Name: Patient Examination Gloves Device Class: Class I Device Classification Number: 21 CFR 880.6250 Product Code: LZA
#### 3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE
Predicate Device: K192333 Device Name: Blue Nitrile Examination Gloves Powder Free Device Classification Name: Patient Examination Gloves Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZA Review Panel: General Hospital
#### 4. DEVICE DESCRIPTION
The subject device in this 510(k) Notification is LYDUS Nitrile Examination Gloves, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
#### 5. INTENDED USE OF THE DEVICE
L YDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
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## 6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE DEVICES
| | | DEVICE PERFORMANCE | | | |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--------------------------------------------------|------|
| CHARACTERISTICS | PREDICATE | SUBJECT | REMARKS | | |
| 510(k) Number | K192333 | K203191 | - | | |
| Device Name | Blue Nitrile<br>Examination Gloves<br>Powder Free | Nitrile Examination<br>Gloves, Powder Free | - | | |
| Product Code | LZA | LZA | Same | | |
| Intended Use | JR MEDIC Blue Nitrile<br>Examination Gloves<br>Powder Free is<br>disposable devices<br>intended for medical<br>purpose that are worn<br>on the examiner's<br>hand or fingers to<br>prevent contamination<br>between patient and<br>examiner. The device is<br>for over the-counter use. | LYDUS Nitrile<br>Examination Gloves,<br>Powder Free is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's hand<br>or fingers to prevent<br>contamination between<br>patient and examiner. | Same | | |
| Materials of Use<br>(ASTM<br>D6910/D6910M-19) | Nitrile compound | Nitrile compound | Same | | |
| Color | Blue | Blue | Same | | |
| Texture | Finger Textured | Finger Textured | Same | | |
| Size<br>(ASTM D6319-19) | Small, Medium, Large,<br>Extra Large | Small, Medium, Large,<br>Extra Large | Same | | |
| Sterilization | Non-sterile | Non-sterile | Same | | |
| Usage | Single usage | Single usage | Same | | |
| Dimensions<br>(ASTM D6319-19) | Length Min. 230 min<br>Width Min 95+/-10 mm<br>(for medium size) | Length Min. 230 min<br>Width Min 95+/-10 mm<br>(for medium size) | Same | | |
| Physical Properties<br>(ASTM D6319-19) | <b>Before Aging</b><br>Tensile Strength<br>Min 14 Mpa<br>Ultimate Elongation<br>Min 500% | <b>Before Aging</b><br>Tensile Strength<br>Min 14 Mpa<br>Ultimate Elongation<br>Min 500% | Same | | |
| | <b>After Aging</b><br>Tensile Strength<br>Min 14 Mpa<br>Ultimate Elongation<br>Min 400% | <b>After Aging</b><br>Tensile Strength<br>Min 14 Mpa<br>Ultimate Elongation<br>Min 400% | | | |
| | Thickness<br>(ASTM D6319-19) | Palm min 0.05 mm<br>Finger min 0.05 mm | | Palm min 0.05 mm<br>Finger min 0.05 mm | Same |
| | Powder Free<br>(ASTM D6319-19) | ≤2 mg/glove | | ≤2 mg/glove | Same |
| | Freedom from Holes<br>(Water Tight -1000 ml) -<br>ASTM D6319-19 (Cross<br>Reference D5151) | Passed | | Passed | Same |
| | Biocompatibility -<br>SKIN SENSITIZATION -<br>ISO 10993-10: 2010 (E) | Under the conditions of<br>study not an irritant | | Under the conditions of<br>study not an irritant | Same |
| Biocompatibility -<br>SKIN IRRITATION - ISO<br>10993-10: 2010 (E) | Under the conditions of<br>the study not a sensitizer | Under the conditions of<br>the study not a<br>sensitizer | Same | | |
| Biocompatibility -<br>IN VITRO<br>CYTOTOXICITY - ISO<br>10993-5: 2009(E) | Under the conditions of<br>the cytotoxicity study,<br>additional acute<br>systemic toxicity testing<br>results showed no<br>systemic toxicity<br>concern. | Exhibit cytotoxic<br>reactivity at 100%<br>extract concentration<br>(Grade 4 with neat<br>extract).<br>Non-cytotoxic<br>reactivity at 50%, 25%,<br>12.5% and 6.25%<br>extract concentration. | Similar | | |
| Biocompatibility -<br>ACUTE SYSTEMIC<br>TOXICITY - ISO 10993-<br>11: 2017(E) | Under the conditions of<br>the study no systemic<br>toxicity | No systemic toxicity<br>under the experimental<br>conditions employed | Similar | | |
| Manufacturer(s) | JR Engineering &<br>Medical Technologies<br>(M) SDN.BHD.,<br>Malaysia | Nathan Trading Co.,<br>Ltd., Thailand | | | |
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There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-19.
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## 7. NON-CLINICAL TESTING SUMMARY
#### PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| ASMT D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application - Physical<br>Dimensions Test | To determine the<br>width, length, and<br>thickness of the<br>gloves | Width:<br>91 mm (Mean)<br>(for medium size)<br>Length:<br>241 mm (Mean)(for medium size)<br>Thickness: Finger -<br>0.13 mm (Mean) Palm -<br>0.09 mm (Mean) | Passed |
| ASMT D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application - Physical<br>Requirements Test | To determine the<br>tensile strength<br>and ultimate<br>elongation before<br>and after<br>acceleration aging | Before Acceleration Aging: Tensile<br>Strength (MPa): 34 (Mean) Ultimate<br>Elongation (%): 601 (Mean)<br>After Acceleration Aging:<br>Tensile Strength (MPa): 34 (Mean)<br>Ultimate Elongation (%): 571 | Passed |
| ASTM D6319-19<br>(ASTM D5151-11)<br>Standard Test Method<br>for Detection of Holes in<br>Medical Gloves | To determine the<br>holes in the<br>gloves | (Mean)<br>AQL 2.5 | Passed |
| ASMT D6319-19<br>(ASTM D6124-11)<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves | To determine the<br>residual powder<br>in the gloves | < 2.0 mg/glove | 0.80<br>mg/glove |
#### BIO-COMPATIBILITY DATA
| Test Method | Purpose | Acceptance<br>Criteria | Result |
|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------|
| ISO 10993-10 Biological evaluation<br>of medical devices - Part 10: Tests<br>for skin irritation and skin<br>sensitization | To determine the potential of the<br>material under test to produce<br>skin irritation in rabbits | Under the<br>condition of<br>study not an<br>irritant | Under the condition of<br>study not an irritant |
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| ISO 10993-10 Biological evaluation<br>of medical devices - Part 10: Tests<br>for skin irritation and skin<br>sensitization | To determine the skin<br>sensitization potential of the<br>material both in terms of<br>induction and elicitation in<br>guinea pigs. | Under the<br>conditions of the<br>study not a<br>sensitizer. | Under the conditions of<br>the study not a<br>sensitizer. |
|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-5 Biological evaluation<br>of medical devices - Part 5: Tests<br>for in vitro cytotoxicity | To evaluate the in vitro cytotoxic<br>potential of the test item (both<br>inner and outer surface) Extracts<br>in L-929 mouse fibroblasts cells<br>using elution method | Under the<br>conditions of<br>study non<br>cytotoxic | Exhibit cytotoxic<br>reactivity at 100%<br>extract concentration<br>(Grade 4 with neat<br>extract).<br>Non-cytotoxic<br>reactivity at 50%, 25%,<br>12.5% and 6.25%<br>extract concentration. |
| ISO 10993-11:2017 Biological<br>evaluation of medical devices-<br>Part 11: Tests for acute systemic<br>toxicity | The test item was evaluated for<br>acute systemic toxicity in Swiss<br>Albino Mice | Under the<br>conditions of the<br>study no systemic<br>toxicity | Under the conditions of<br>the study no systemic<br>toxicity |
#### 8. CLINICAL TESTING SUMMARY
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
## 9. CONCLUSION
The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(k) submission, the LYDUS Nitrile Examination Gloves, Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicate device K192333
