← Product Code [LZA](/productcode/LZA) · K222531 # Synthetic Polymer Glove - Polyethylene (Black) (K222531) _Ur Industry Sdn Bhd · LZA · Jan 22, 2023 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K222531 ## Device Facts - **Applicant:** Ur Industry Sdn Bhd - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Jan 22, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use Powder Free Polyethylene Examination Gloves, is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use. ## Device Story Synthetic Polymer Glove (Polyethylene) is a non-sterile, powder-free, disposable patient examination glove. Device acts as a physical barrier to prevent cross-contamination between patient and examiner. Used in clinical or home settings by healthcare providers or patients. Input is the user's hand; output is a protective barrier. Device is manufactured from low-density polyethylene. Performance is verified through physical property testing (tensile strength, elongation) and biocompatibility assessments. Benefits include protection against contamination during medical examinations. ## Clinical Evidence No clinical data. Bench testing only. Device demonstrated compliance with ASTM D6319-19 (dimensions, physical properties, freedom from holes), ASTM D6124-06 (residual powder), and ISO 10993 series (cytotoxicity, sensitization, irritation). ## Technological Characteristics Material: Low-density polyethylene. Form factor: Disposable, powder-free, non-sterile examination glove. Sizes: Small, Medium, Large, X-Large, XX-Large. Standards: ASTM D6319-19, ASTM D412-16, ASTM D573-04, ASTM D5151-19, ASTM D6124-06, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021. ## Regulatory 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 - Thermoplastic Elastomer (TPE) Hybrid Examination Glove ([K210463](/device/K210463.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/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 & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 22, 2023 UR Industry SDN BHD % A.C. Thirumaran Official Correspondent Integrated Assessment Services Pvt Ltd No. 1919-1920. Building D3, Miniie Plaza, Shuixi Road, Chennai, Tamil Nadu 600040 India Re: K222531 Trade/Device Name: Synthetic Polymer Glove - Polyethylene (Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 31, 2022 Received: January 3, 2023 Dear A.C. Thirumaran: 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 (QS) 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 mediation-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. # Bifeng Qian -S Bifeng Qian, M.D., Ph.D. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222531 Device Name Synthetic Polymer Glove - Polyethylene (Black) Indications for Use (Describe) Powder Free Polyethylene Examination Gloves, is a non-sterile disposable device intended for medical purposes 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) |X | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) Summary ## SYNTHETIC POLYMER GLOVE-POLYETHYLENE (BLACK) Preparation Date: 31/12/2022 #### 510k: K222531 #### 1. Submitter: Company Name: UR Industry Sdn. Bhd. Company Address: NO. 180, Jalan Murni 9, Taman, Perindustrian Murni, 81400 Senai, Johor Darul Takzim, Malaysia. Facility Registration Number: 3018161411 Contact person: Mr. Chua Song Han Managing Director #### 2. Name of the Device Trade Name / Proprietary Name: Synthetic Polymer Glove- Polyethylene (Black) Device Common Name: Polyethylene Examination gloves. Device Classification Name: Non-Powdered Patient Examination Glove (21 CFR 880.6250). Device Class: Class I. Product Code: LZA #### 2. Official Correspondent Mr. A.C. Thirumaran Integrated Assessment Services Private Limited No.1495, Manasarovar, 16th Main Road, Anna Nagar west, Chennai- 600040, India. Email: iasfda16@gmail.com #### 4. Identification of the Legally Marketed Device (Predicate Device): 510K: K210463 Submitter: Xuzhou Full Sun Medical Products Ltd Trade/Device Name: Thermoplastic Elastomer (TPE) Hybrid Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA #### 5. Device Description The subject device in this 510(k) Notification is Synthetic Polymer- polyethylene - Powder Free Examination Glove. The subject device is a patient examination glove made from Low Density Polyethylene material, Black 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. The available sizes of the subject devices are Small, Medium, Large. X-Large & XX Large. {4}------------------------------------------------ # 6. Intended use of the Device Powder Free Polyethylene Examination Gloves, is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use. ## 7. Technological characteristics Comparison for the proposed and predicate devices | Characteristics | Acceptance Criteria | Subject device:
Synthetic Polymer Glove-
polyethylene (Black)
UR INDUSTRY SD BHD
(Small/ Medium/ Large/X
large/XX Large)
K222531 | Predicate Device
Thermoplastic Elastomer
(TPE) Hybrid Examination
Glove
Xuzhou Full Sun Medical
Products Ltd.
(Small/ Medium/ Large/X
large)
K210463 | Remarks | |---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | LZA | LZA | LZA | same | | Intended use | 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. The device
is for over- the- counter use. | This powder free patient
examination glove is a
disposable device intended for
medical purposes that is worn
on the examiner's hand to
prevent contamination between
patient and examiner. The
device is for over- the- counter
use. | Thermoplastic Elastomer (TPE)
Hybrid Examination Glove is a
non-sterile disposable device
intended for medical purpose
that is worn on the examiner's
hands or fingers to prevent
contamination between patient
and examine | same | | Material used | Low Density Polyethylene
material | Low Density Polyethylene
material | Low Density Polyethylene
material | same | | Color | N/A | Black | Blue | Different | | Sterility | Sterile/Non-sterile | Non sterile | Non sterile | same | | Single use | Single use | Single use | Single use | same | | | Overall Length (mm) Min
230mm | Avg. value of 13 pcs (mm)
Small - 261.53
Medium- 260.1
Large- 260.08
X-large- 259.8
XX -Large - 268.5 | Complies with ASTM D6319-19
230 mm min | same | | Dimensions | Width (±10 mm)
Small - 80
Medium- 95
Large-110
X-large-120
XX -Large 130 | Avg. value of 13 pcs (mm)
Small - 86.30
Medium- 99.4
Large-115.23
X-large-123.54
XX -Large 134.5 | Small - 104 ± 5 mm
Medium- 107 ± 5 mm
Large-115 ± 5 mm
X-large-123 ± 5 mm | Our product of all
ranges meets the
ASTM D6319
dimensional
requirement.
Whereas, the
predicate device has
exceeded in
dimensional
requirement of
ASTM D6319 and
claims to have
adhered to their
Internal Standard
and nature of the
material. | | | Thickness at Palm (mm) Min;
0.05 mm | Palm - 0.06 mm. | Palm - 0.05 mm min. | same | | Characteristics | Acceptance Criteria | Subject device:
Synthetic Polymer Glove-
polyethylene (Black)
UR INDUSTRY SD BHD
(Small/ Medium/ Large/X
large/XX Large)
K222531 | Predicate Device
Thermoplastic Elastomer
(TPE) Hybrid Examination
Glove
Xuzhou Full Sun Medical
Products Ltd.
(Small/ Medium/ Large/X
large)
K210463 | Remarks | | | Thickness at Finger Tip (mm)
Min 0.05 mm | Finger - 0.06 mm. | Finger - 0.05 mm min | same | | Physical
Properties -
ASTM D412-16
& ASTM
D573-04 | Before Ageing - Tensile
strength = 14MPa, min. | Tensile Strength (MPa)
Avg. value of 13 pcs
Small - 18.6
Medium -17.45
Large -18.53
X Large -17.4
XX Large 18.69 | Tensile Strength 14 MPa, min. | same | | | Before Ageing - Ultimate
elongation = 500% | Avg. values of 13 pcs
Ultimate elongation (%)
Small - 653.43
Medium - 673.5
Large - 689.15
X Large - 636.56
XX Large - 645.83 | Elongation: Before Aging: 500%
min. | same | | | After Ageing - Tensile strength
= 14MPa, min. | Tensile Strength (MPa)
Avg. values of 13 pcs
Small- 17.8
Medium - 18.13
Large - 18.61
X Large - 18.3
XX Large - 18.34 | After Aging: 14 MPa, min. | same | | | After Ageing – Ultimate
elongation = 400% | Avg. values of 13 pcs
Ultimate elongation (%)
Small - 645.18
Medium - 680.2
Large - 686.15
X Large - 614.58
XX Large - 636.87 | After Aging: 400% min. | same | | Freedom from
pinholes ASTM
D5151-19 | AQL 2.5 Inspection Level G-1 | Free from Holes | Free from Holes | same | | Residual Powder
ASTM D6124-06 | < 2.0 mg/pc | < 2mg per glove | < 2mg per glove | same | | Bio- Compatibility | ISO 10993-23:2010 Biological
evaluation of medical devices:
Tests for irritation | Non-Skin irritant | Non-Skin irritant | same | | | ISO 10993-10:2021 Biological
evaluation of medical devices -
Part 10: Tests For skin
sensitization | No contact sensitization | No contact sensitization | same | | | ISO 10993-5:2009 Biological
evaluation of medical devices -
Part 5: Tests for in vitro
cytotoxicity | No In Vitro cytotoxicity | No In Vitro cytotoxicity | Same | {5}------------------------------------------------ # UR INDUSTRY SDN BHD Synthetic Polymer Glove- Polyethylene 510k Premarket submission- Traditional {6}------------------------------------------------ ## UR INDUSTRY SDN BHD Synthetic Polymer Glove- Polyethylene 510k Premarket submission- Traditional # 8. Summary of non-clinical testing results Iconic Nitrile Glove was tested and found in conformance with the following standards: | ASTM D6319-19 | Standard Specification for Nitrile Examination Gloves for Medical Application | |-------------------|----------------------------------------------------------------------------------| | ISO 10993-5:2009 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | | ISO 10993-10:2021 | Biological evaluation on medical device Part 10: Test for Skin Sensitization | | ISO 10993-23:2021 | Biological evaluation of medical devices Part 23: Tests for irritation | | Test
Methodology | Purpose | Acceptance
Criteria | Average Results | | | | | Final
status | |---------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------|--------------------------|-------------------------|---------------------------|----------------------------|-----------------| | | Sterility | - | Small
Non
sterile | Medium
Non
sterile | Large
Non
sterile | X Large
Non
sterile | XX Large
Non
sterile | - | | | Freedom
from hole -
ASTM
D5151-19 | AQL 2.5 | Pass | Pass | Pass | Pass | Pass | Pass | | | Dimension -
width,
Length,
Thickness | Overall Length
(mm) Min
230mm. | 261.53 | 260.1 | 260.08 | 259.8 | 268.5 | Pass | | | | Width (±10
mm)
Small - 80
Medium- 95
Large-110
X-large-120
XX -Large -130 | 86.30 | 99.4 | 115.23 | 123.54 | 134.5 | Pass | | | | Thickness at Palm & fingertip Min: 0.05 mm | | | | | | | | | | Palm | 0.06 | 0.06 | 0.06 | 0.06 | 0.06 | Pass | | | | Fingertip | 0.06 | 0.06 | 0.06 | 0.06 | 0.06 | Pass | | | | a. Before Aging | | | | | | | | ASTM D6319-
19 | Physical
properties
before aging,
after
accelerated
aging | Tensile
Strength=14
MPa, min. | 18.6 | 17.45 | 18.53 | 17.4 | 18.69 | Pass | | | | Ultimate
Elongation=
500%
min | 653.43 | 673.5 | 689.15 | 636.56 | 645.83 | Pass | | | | | b. After Accelerated Aging | | | | | | | | | Tensile
Strength=14
MPa, min. | 17.8 | 18.13 | 18.61 | 18.3 | 18.34 | Pass | | | | Ultimate
Elongation=
400
% min | 645.18 | 680.2 | 686.15 | 614.58 | 636.87 | Pass | | | Powder-free
Residue
exceeds
maximum limit
- ASTM
D6124-06 | < 2.0 mg per
glove | Not
detected | Not
detected | Not
detected | Not
detected | Not
detected | Pass | | ISO 10993-5 | Test for Invitro
cytotoxicity | Non- Cytotoxic | | | Pass | | | | {7}------------------------------------------------ ## UR INDUSTRY SDN BHD Synthetic Polymer Glove- Polyethylene 510k Premarket submission- Traditional | ISO 10993-10 | Test for
irritation and
Skin
Sensitization | Non - Skin
Sensitized | Pass | |--------------|-----------------------------------------------------|--------------------------|------| | ISO 10993-23 | Tests for
irritation | Non-Irritant | Pass | ## 9. Summary of clinical Performance data Not applicable - Clinical data was not used to assess performance of the subject device. #### 10. Conclusion The Conclusion drawn from the non-Clinical test demonstrates that the subject device - Synthetic Polymer Glove- polyethylene (Black) is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K210463. --- **Source:** [https://fda-staging.innolitics.com/device/K222531](https://fda-staging.innolitics.com/device/K222531) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com