Pediatric Safety OEM | Kids Nasal Strips & Tapes
Pediatric Medical Device OEM

Engineered for delicate skin.
Validated for parent trust.

Manufacturing pediatric nasal strips and gentle mouth tapes with uncompromising adherence to safety standards. ISO 13485 compliant.

Child sleeping peacefully with nasal strip

Audited & Certified Manufacturing Standards

ISO 13485 Certification
13485:2016 Quality Mgmt
CE Mark
Conformity European
EU MDR Compliant
EU MDR 2017/745
FDA Registered
Registered US Facility
TUV SUD Certification
TÜV SÜD Tested

Pediatric Indications & Use Cases

Gentle, safe, and effective solutions designed specifically for younger patients.

Nasal Congestion

Nasal Congestion

Mechanical dilation for improved airflow during sleep, helping children breathe easier without medication.

Mouth Breathing

Mouth Breathing

Gentle habit correction with safety-first central vents to ensure oral safety while promoting nasal breathing.

Sensitive Skin

Sensitive Dermis

Specially formulated for developing skin barriers using hypoallergenic, latex-free medical grade materials.

Supervised Use

Supervised Use

Designed for safe application and removal by parents or guardians to ensure proper placement and comfort.

Laboratory Verified Safety

We don't just claim "gentle" — we prove it. Every batch is subject to rigorous biological evaluation standards (ISO 10993) to ensure pediatric biocompatibility.

Cytotoxicity Tested

Passed ISO 13485 standards. Materials show zero toxic effect on cell cultures, ensuring cellular safety for long-term skin contact.

Skin Sensitization

Verified under ISO 13485. Formulated to minimize potential for allergic reaction or delayed hypersensitivity in children.

Laboratory Safety Verification Report
VERIFIED

Irritation Free

Primary Skin Irritation tests confirm < 0.4 index score. Safe for repeated nightly application on delicate facial areas.

Full Traceability

Every production lot includes COA (Certificate of Analysis) and raw material tracing to ensure no cross-contamination.

Biocompatible Material Selection

We utilize exclusively medical-grade substrates free from common allergens. No latex, no parabens, no fragrance.

Hypoallergenic Non-Woven

Hypoallergenic Non-Woven

High porosity ensures skin respiration during overnight wear.

Pure Medical Cotton

Pure Medical Cotton

Natural fiber option for maximum softness and minimal environmental impact.

Soft-Touch Synthetic

Soft-Touch Synthetic

Smooth, friction-free surface designed to prevent snagging on bedding.

Gentle removal of nasal strip from child's skin showing no redness

Adhesion Engineered for Pain-Free Removal

Adult adhesives can cause trauma to pediatric skin. Our specific pediatric formulation reduces peel force by 35% compared to standard strips, while maintaining sufficient hold for 8-10 hours.

Solvent-Free Gel Acrylic

Eliminates harsh chemical residue.

Micro-Porous Structure

Allows moisture evaporation to prevent skin maceration.

Risk Mitigation & Quality Assurance

We prioritize regulatory compliance to protect your brand from liability and platform policy violations.

Quality control and compliance lab setting

Choke Hazard Prevention

Single-piece construction with no detachable small parts.

Biocompatibility

Passed ISO 13485 testing for cytotoxicity and sensitization.

Airflow Vents

Mouth tapes feature mandatory central breathing vents for safety.

Platform Compliance

Documentation ready for Amazon Kids & Medical categories.

Supply Chain Reliability

1
Scalable Production

From pilot runs to mass retail fulfillment.

2
Vision Inspection

Automated 100% surface defect scanning.

3
Sterile Packaging

Clean-room packing to prevent contamination.

4
Global Logistics

End-to-end shipping options.

Pediatric Mouth Tape Design Styles

Conservative, safety-first designs engineered to avoid full-seal coverage. Choose a style first — we’ll calibrate materials and low-tack adhesion based on your market and compliance needs.

Platform-Safe
X-Vent Safety Mouth Tape

X-Vent Safety Design

Ref: PED-MT-DES-01

  • Designed to avoid full-seal coverage and maintain airflow.
  • Low-tack adhesion tuned for comfortable morning removal.
  • Recommended for supervised pediatric use only.
Safety Vent
O-Vent Central Air Passage Tape

O-Vent (Central Air Passage)

Ref: PED-MT-DES-02

  • Central opening helps ensure airflow is not fully blocked.
  • Rounded perimeter reduces edge irritation and peeling.
  • Suitable for family-care brands focused on safety-first design.
Partial Seal
Two-Tab Comfort Design Tape

Two-Tab Comfort Design

Ref: PED-MT-DES-03

  • Reduced coverage helps lower claustrophobic feel for kids.
  • Easier alignment for parents during supervised application.
  • Designed for gentle adhesion and low-residue removal.
Download Pediatric Mouth Tape Guide (PDF)

Safety-first designs intended for supervised pediatric use. No obligation.

Retail-Ready Packaging

Parents buy with their eyes, but they trust with information. We design packaging that balances shelf-appeal with necessary medical warnings and usage instructions.

  • ✓ Tamper-evident seals
  • ✓ Clear age-grading display
  • ✓ Multi-language instruction leaflets
Professional medical packaging for pediatric nasal strips

Common Safety & Compliance Queries

Q. How does the adhesive differ from adult nasal strips?

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Pediatric skin is thinner and more sensitive. Our formulation uses a medical-grade, low-tack acrylic adhesive calibrated with lower peel force than adult products. It provides secure overnight hold while allowing gentle removal with minimal risk of redness or epidermal irritation.

Q. Are your pediatric mouth tapes compliant with platform safety policies?

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Yes. For pediatric use, we only support mouth tape designs with integrated breathing vents or X-shaped openings. These designs ensure airflow is never fully obstructed and align with marketplace safety guidelines for minors.

Q. Do you recommend a minimum age for use?

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Age recommendations depend on product type and market regulations. Most pediatric nasal strip designs are intended for supervised use by children, with clear age guidance and warnings defined during packaging and compliance review.

Q. What materials are suitable for children’s sensitive skin?

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We typically recommend soft non-woven substrates or medical cotton for pediatric products. Material selection prioritizes breathability, skin comfort, and long-term supply stability rather than novelty materials.

Q. How do you reduce skin irritation and complaint risk?

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Our pediatric designs follow a skin-first approach, including low-tack adhesion, smooth edge cutting, and residue-free removal. Products are reviewed to minimize irritation risks before mass production.

Q. Can you support private label pediatric brands?

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Yes. We support private label development with conservative design guidance, child-safe materials, and packaging layouts reviewed for platform and regulatory requirements before launch.

Q. What certifications or documentation can you provide?

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We can provide relevant documentation such as ISO certification, material safety data sheets, and quality records to support your internal review or platform audits.

Q. Is pediatric sampling available before mass production?

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Yes. We encourage sampling and evaluation before production. Pediatric sample kits allow brands to assess comfort, adhesion, and usability prior to confirming specifications.
OEM/ODM Manufacturer

Eliminate Supply Chain Risk.
Scale with Confidence.

The Risk of Generic Suppliers

Inconsistent adhesives, "quality fade" over time, and lack of FDA documentation can lead to immediate Amazon listing suspensions.

Direct Factory Control

We manufacture in our own ISO 13485 facility using medical-grade hypoallergenic hydrogels. Full traceability and Multiple Shipping Options Available.

Rapid Market Expansion

Launch faster with 7-day prototyping and flexible MOQs. Join 500+ distributors building their brand on our reliable quality.

Get Factory Pricing

Request samples & COA documents

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