← Product Code [LZA](/productcode/LZA) · K212085 # Siam NTD+ Nitrile Powder-Free Examination gloves (K212085) _Siam Ntd Corporation Co., Ltd. · LZA · Dec 11, 2021 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K212085 ## Device Facts - **Applicant:** Siam Ntd Corporation Co., Ltd. - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Dec 11, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES 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 nitrile butadiene rubber examination glove; worn on hand/fingers to provide barrier protection; prevents cross-contamination between patient and examiner. Non-sterile; single-use; ambidextrous; finger-textured; blue color. Available in small, medium, large, and extra-large sizes. Used in clinical settings by healthcare providers. Acts as physical barrier; no electronic or software components. ## Clinical Evidence Bench testing only. Performance data includes physical dimensions (ASTM D6319-19), tensile strength and elongation (before/after aging), freedom from holes (ASTM D5151), and residual powder content (ASTM D6124). Biocompatibility testing conducted per ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin irritation/sensitization), and ISO 10993-11 (acute systemic toxicity). ## Technological Characteristics Material: Nitrile butadiene rubber. Form: Finger-textured, ambidextrous, blue, non-sterile, single-use. Standards: ASTM D6319-19 (dimensions, physical properties, powder-free, holes). Biocompatibility: ISO 10993-5, 10993-10, 10993-11. No energy source or software. ## 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 - Blue Nitrile Examination Gloves Powder Free ([K192333](/device/K192333.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 USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". December 11, 2021 Siam NTD Corporation Co., Ltd. Taweesak Waideemaneetrakoon Manufacturer Manager Third Party Review Group 120/259 Moo1, Bueng Yitho Sub-district, Thanyaburi Pathum Thani. Thailand Re: K212085 Trade/Device Name: Siam NTD+ Nitrile Powder-Free Examination gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 17, 2021 Received: November 19, 2021 Dear Taweesak Waideemaneetrakoon: 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. For Clarence W. Murray, III, PhD 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 Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K212085 Device Name Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES Indications for Use (Describe) Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES 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. 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}------------------------------------------------ Image /page/3/Picture/2 description: The image shows a logo for Siam NTD+. The logo features a globe with blue continents and white oceans, held by two blue hands. The text "Siam NTD+" is written in red, with "Siam" above the globe and "NTD+" to the right of the globe. The logo is likely for a company or organization related to Siam NTD+. Siam NTD Corporation Co., LTD. 120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731 # 510(k) Summary The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92. Date Summary Prepared: November 23, 2021 ### 1. Submitter | Company name : | Siam NTD Corporation Co., Ltd. | |-------------------|--------------------------------------------------------------------------------------------| | Company address : | 120/259 Moo1, Bueng Yitho Sub-district, Thanyaburi District
Pathum Thani Thailand 12130 | | Telephone: | +66863257731 | | Contact Person : | Mr. Taweesak Waideemaneetrakoon,
Manufacturer Manager | | Phone number : | +66899268831 | | E-mil : | taweesak8831@gmail.com | ### 2. Name of the Device: | Proprietary Name: | Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES | |----------------------|--------------------------------------------------| | Common Name: | Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES | | Classification Name: | POLYMER PATIENT EXAMINATION GLOVE | | Regulatory Class: | I | | Product Code: | LZA | | Regulation Number: | 21 CFR 880.6250 | | Review Panel: | General Hospital | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows a logo for Siam NTD+. The logo features a globe with blue continents and white landmasses. Two blue hands are cupping the globe from below. The text "Siam NTD+" is written in red and blue above the globe. The plus sign is slightly raised and smaller than the other letters. D Corporation Co., LTD. 1, Bueng Yitho Sub-district, Thanyaburi District ani Thailand 12130 Telephone: +66909097731, +66863257731 ### 3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE K192333, JR MEDIC, JR Engineering & Medical Technologies (M) SDN.BHD. Predicate: Device Name: Blue Nitrile Examination Gloves Powder Free Device Classification Name: Polymer Patient Examination Glove Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZA Review Panel: General Hospital #### 4. DEVICE DESCRIPTION Siam NTD* NITRILE POWDER-FREE EXAMINATION GLOVES is a glove made from nitrile butadiene rubber Latex that covers the hand up to the wrist. It is cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. It has 4 sizes, i.e. small, medium, large and extra large. All variations share the same blue color. The glove is non-sterile and is for single use only, to be discarded after each examination is performed. It acts as a barrier between the examiner and the subject being examined in order to prevent contamination between them. #### 5. INDICATIONS FOR USE. Siam NTD* NITRILE POWDER-FREE EXAMINATION GLOVES 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. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a logo with the text "Siam NTD+" in red and blue, superimposed on a globe. The globe is blue and white, with the continents outlined in white. Two blue hands are cupping the globe from below. The logo appears to represent a global organization or company named Siam NTD+. Siam NTD Corporation Co., LTD. 120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731 # 6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE ### DEVICES | | DEVICE PERFORMANCE | | | |-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | CHARACTERISTICS | PREDICATE | SUBJECT | REMARKS | | 510(K) Numbers | K192333 | K212085 | | | Device Name | JR MEDIC Blue
Nitrile Examination Gloves
Powder Free | Siam NTD+ NITRILE
POWDER-FREE
EXAMINATION GLOVES | | | Product Code | LZA | LZA | Same | | Intended Use | JR MEDIC Blue 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. | Siam NTD+ NITRILE
POWDER-FREE
EXAMINATION GLOVES 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. | Same | | Material of Use
(ASTM D6910/D6910M-
19) | Nitrile Compound | Nitrile Compound | Same | | Color | Blue | Blue | Same | | Texture | Finger Textured | Finger Textured | Same | | Size (ASTM D6319-19) | Small, Medium, Large, Extra
Large | Small, Medium, Large, Extra
Large | Same | | Sterilization | Non-Sterile | Non-Sterile | Same | | Usage | Single Usage | Single Usage | Same | | Dimensions
(ASTM
D6319-19) | Length Min. 230 min, Width
Min 95+/-10 mm (for
medium size) | Length Min. 230 min,
Width Min 95+/-10 mm
(for medium size) | Same | | Physical Properties
(ASTM D6319-19) | Before Aging
Tensile Strength Min 14 Mpa
Ultimate Elongation Min
500%
After Aging
Tensile Strength Min 14 Mpa
Ultimate Elongation Min
400% | Before Aging
Tensile Strength Min 14 Mpa
Ultimate Elongation Min
500%
After Aging
Tensile Strength Min 14 Mpa
Ultimate Elongation Min
400% | Same | | Thickness
(ASTM D6319-19) | Palm Min 0.05 mm
Finger Min 0.05 mm | Palm Min 0.05 mm
Finger Min 0.05 mm | Same | | Powder-Free
(ASTM D6319-19) | ≤2 mg/glove | ≤2 mg/glove | Same | | Freedom from Holes
(Water Tight-1000 ml) -
ASTM D6319-19 (Cross
Reference D5151) | Passed | Passed | Same | | Biocompatibility-SKIN
SENSITIZATION - ISO
10993-10:2010 (E) | Under the conditions of
study not a sensitizer | Under the conditions of study
not a sensitizer | Same | | Biocompatibility-SKIN
IRRITATION – ISO
10993-10:2010 (E) | Under the conditions of
study not an irritant | Under the conditions of study
not an irritant | Same | | Biocompatibility – IN
VITRO
CYTOTOXICITY – ISO
10993-5:2009(E) | Under the conditions of the
study, cytotoxic. Additional
testing was performed to
determine if this was a
systemic toxicity concern. | Under the conditions of the
study, concentration of
extract, 100%, 66%, 44%,
30%, 20% was cytotoxic.,
13%, 9%, 6% are not
cytotoxic and therefore the
device extracts were evaluated
by ISO 10993-11 - Test for
Acute Systemic Toxicity. | Same | | Biocompatibility -
ACUTE SYSTEMIC
TOXICITY – ISO
10993-11:2017(E) | Under the conditions of the
study the device extracts do
not pose a systemic toxicity
concern | Under the conditions of the
study did not reveal any
systemic toxicity. | Same | | Manufacturer(s) | JR Engineering & Medical
Technologies (M)
SDN.BHD | TOP GLOVE MEDICAL
(THAILAND) CO., LTD | | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows a logo with the words "Siam NTD+" in red letters. The letters are positioned in front of a globe with blue hands underneath it. The globe is showing the continents of North and South America. The logo appears to be for a company or organization called Siam NTD+. 120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731 {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows a logo with the text "Siam NTD+" in red and blue letters. The text is positioned above a blue globe with white continents. Two blue hands are cupping the globe from below. The logo appears to represent a global organization or initiative, possibly related to technology or development, given the "NTD" abbreviation. 120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731 There are no significant differences between the three products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-19. ## 7. NON-CLINICAL TESTING SUMMARY ## PERFORMANCE DATA | Test Method | Purpose | Acceptance Criteria | Result | |-------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ASMT D6319-19 | To determine the
width, length, and
thickness of the
gloves | Width:
Small: $80\pm10$ mm
Medium: $95\pm10$ mm
Large: $110\pm10$ mm | Width:
Small: 84 mm
Medium: 95 mm
Large: 104 mm | | Standard Specification
for Nitrile Examination
Gloves for Medical | | | | | Application - Physical
Dimensions Test | To determine the
tensile strength
and ultimate
elongation before
and after | X-Large: 120±10 mm
Length:
Small: 220 mm
Medium: 230mm
Large: 230 mm
X-Large: 230 mm
Thickness:
Finger: 0.05 mm min
for all sizes
Palm: 0.05 mm min
for all sizes | X-Large: 114 mm
Length:
Small: 247 mm
Medium: 248 mm
Large: 247 mm
X-Large: 248 mm
Thickness:
Finger:
Small: 0.11 mm
Medium: 0.10 mm
Large: 0.10 mm
X-Large: 0.10 mm
Palm:
Small: 0.07 mm
Medium: 0.07 mm
Large: 0.07 mm
X-Large: 0.07 mm
Cuff:
Small: 0.06 mm
Medium: 0.05 mm
Large: 0.05 mm
X-Large: 0.06 mm | | | | | | {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows a logo for Siam NTD+. The logo features a globe with blue hands holding it up. The text "Siam" is in red, and "NTD+" is in blue. The globe shows the continents of the world. 120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731 {9}------------------------------------------------ r Image /page/9/Picture/1 description: The image shows a logo for Siam NTD+. The logo features a globe with the Americas prominently displayed, cradled by two blue hands. Above the globe, the words "Siam NTD+" are written, with "Siam" in red and "NTD+" in blue. The overall design suggests a global reach or international focus for the organization. # Siam NTD Corporation Co., LTD. 120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731 | Requirements Test | acceleration aging | After Acceleration | | |---------------------------------------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------|------------------------| | | | Aging: Tensile
Strength (MPa): | X-Large: 27.8 Mpa | | | | 14 (Min) for all sizes | Ultimate Elongation: | | | | Ultimate Elongation (%): | Small: 540% | | | | 400 (Min) for all sizes | Medium: 575% | | | | | Large: 580% | | | | | X-Large: 561% | | | | After Acceleration
Aging: | | | | | Tensile Strength: | | | | | | Small: 14.6 Mpa | | | | | Medium: 15.5 Mpa | | | | | Large: 15.4 Mpa | | | | | X-Large: 14.9 Mpa | | | | Ultimate Elongation: | | | | | | Small: 413% | | | | | Medium: 424% | | | | | Large: 446% | | | | | X-Large: 442% | | ASTM D6319-19
(ASTM D5151-11)
Standard Test Method
for Detection of Holes in
Medical Gloves | To determine the
holes in the
gloves | AQL 2.5 | Gloves Passed AQL 1.5 | | ASMT D6319-19
(ASTM D6124-11)
Standard Test Method
for Residual Powder on | To determine the
residual powder
in the gloves | ≤2.0 mg/glove | Small: 0.48 mg/glove | | | | | Medium: 0.35 mg/glove | | | | | Large: 0.38 mg/glove | | | | | X-Large: 0.18 mg/glove | {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows a logo for Siam NTD+. The logo features the words "Siam NTD+" in red letters above a globe. The globe is blue and white, and it is being held by two blue hands. The logo is likely for a company or organization that is involved in international trade or development. 120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731 ## BIO-COMPATIBILITY DATA | Test Method | Purpose | Acceptance
Criteria | Result | |----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 10993-10 Biological
evaluation
of medical devices - Part
10: Tests
for skin irritation and skin
sensitization | To determine the potential
of the
material under test to
produce
skin irritation in rabbits | Under the
condition of
study not an
irritant | Under the condition of
study not an irritant | | ISO 10993-10 Biological
evaluation
of medical devices - Part
10: Tests
for skin irritation and skin
sensitization | To determine the skin
sensitization potential of
the
material both in terms of
induction and elicitation
in
guinea pigs. | Under the
conditions of the
study not a
sensitizer. | Under the conditions of
the study not a
sensitizer. | | ISO 10993-5 Biological
evaluation
of medical devices — Part
5: Tests
for in vitro cytotoxicity | To evaluate the in vitro
cytotoxic potential of the
test item (both inner and
outer surface) Extracts
in L-929 mouse
fibroblasts cells using
elution method | Under the conditions of
study non cytotoxic | Under the conditions of
the study, concentration
of extract,
100%, 66%, 44%, 30%,
20% was cytotoxic.,
13%, 9%, 6% are not
cytotoxic | | ISO 10993-11:2017 | To determine the acute | Under the | Under the conditions of | | Biological evaluation of
medical devices - Part 11:
Tests for acute systemic
toxicity | systemic toxicity
potential of the test item
extracts (both inside and
outer surface) in Swiss
Albino Mice | conditions of the
study no systemic
toxicity | the study did not reveal
any systemic toxicity. | {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows a logo with the words "Siam NTD+" in red and blue letters. The letters are placed above a blue globe with white continents. Two blue hands are cupping the globe from below. The logo appears to represent a global organization or initiative, possibly related to health or development, given the imagery of care and the world. 120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731 ### 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 Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES is as safe, as effective, and performs as well as the legally marketed predicate device K192333 --- **Source:** [https://fda-staging.innolitics.com/device/K212085](https://fda-staging.innolitics.com/device/K212085) **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